Systems, methods, and devices to determine and predict physilogical states of individuals and to administer therapy, reports, notifications, and the like therefor

ABSTRACT

The invention comprises systems, methods, and devices capable of deriving and predicting the occurrence of a number of physiological and conditional states and events based on sensed data. The systems, methods, and devices utilize the predicted and derived states for a number of health and wellness related applications including the administering therapy and providing actionable data for lifestyle and health improvement.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/088,002 entitled Non-Invasive Temperature Monitoring Device filedMar. 22, 2005. U.S. application Ser. No. 11/088,002 is acontinuation-in-part of Stivoric, et al., Apparatus for Detecting HumanPhysiological and Contextual Information, copending U.S. patentapplication Ser. No. 10/227,575 and also claims the benefit of U.S.Provisional Application No. 60/555,280, for an Automated Energy BalanceSystem Including Iterative and Personalized Planning, Intervention andReporting Capability, filed on Mar. 22, 2004.

BACKGROUND

1. Field

The present invention relates to a system for continuous physiologicalmonitoring and in particular to a system for collecting, storing,processing and displaying data primarily related to an individual's bodytemperature. The present invention also relates to a temperaturemeasurement device that utilizes temperature and other detected data toderive and report additional body states, conditions and contexts. Thedevice, while primarily intended for human use, is equally applicable toanimals for veterinary or pet care.

2. Description of the Related Art

Core body temperature is the temperature of the vital organs of anindividual. An abnormally elevated body temperature occurs when anindividual is in a febrile state and can result in denaturation which isa process that causes irreversible loss of protein function, ultimatelyleading to cell death. An abnormally low body temperature causes anindividual to be

in a hypothermic state which can affect and impair the rate at whichchemical reactions in the body take place and possible lead torespiratory or circulatory failure. For many years, the standard fornormal or baseline body temperature has been 98.6° F., or 37° C., beingthe temperature at which the body is attempting to stabilize. However,research has proven that normal body temperature is actually a range oftemperatures. According to the American Medical Association, normal bodytemperature of an individual can range from approximately 97.8° F., or36.5° C., to 99° F., or 37.2° C. Typically, the body maintains a normalor baseline temperature generally within the narrow range of 36.5-37.5°C. Skin temperature is generally recognized as being 2-3° C. cooler thancore, the actual gradient being dependent on many factors, including theambient temperature of the environment surrounding the body andvasomotor tone. The specific normal or baseline measured temperature ofan individual depends on a variety of factors. For example, time of day,recent activity, fluid and food consumption, measurement location and/ormeasurement technique can affect the detected body temperature of anindividual. Also, normal body temperature of a group of individualshaving similar demographics may vary based on these or other factorsincluding age, metabolic rate, gender and if a disease condition ispresent.

Through monitoring of an individual's body temperature over time, theactual normal body temperature or range of temperatures of a specificindividual can be determined. Knowing this vital statistic is importantfor preventing the occurrence of temperature extremes which can causesignificant damage to tissues and cells of the human body. Additionally,an elevated body temperature can result in a febrile seizure, which is abrief convulsion that occurs repeatedly in association with a fever ininfants and children particularly. Febrile seizures are associated witha rapid onset fever and occur in children between the ages of 6 monthsand 6 years of age. Although a febrile seizure does not typically resultin long-term or permanent damage to the individual, there is anassociated risk of bodily injury, as with any type of seizure.

True core body temperature is the temperature of the arterial blood flowfrom the heart and is most accurately measured at the center of theheart. Measurement at this particular location would require pulmonaryartery catheterization, which is not appropriate under mostcircumstances due to the invasive nature of such a procedure.Consequently, body temperature measurement that provides a resultclosest to the blood temperature of the individual must be measured at aconvenient location that is closest to core body temperature. The mostwidely accepted locations for measurement of body temperature are eitherexternal or externally accessible to the body or do not pose significantrisk of injury to the individual. Typically, these locations includeoral, axillary, rectal, and tympanic. However, the temperaturemeasurement at any of these sites is not true core body temperature andtherefore has an associated error or variance from that core bodytemperature, depending on the location.

One factor affecting the accuracy of temperature measurements is thatdifferent measurement locations have different rates of perfusion.Perfusion generally refers to the release of nutrient compounds neededby the cells to perform vital functions. Perfusion is further defined asthe amount of arterial blood flow required to accomplish the release anddistribution of nutrient compounds to the different areas of the body.Accordingly, perfusion can be correlated to factors indicative of bloodflow such as blood temperature, because an area that is properlyperfused has an adequate blood supply flowing through that area.

The hypothalamus of the human body attempts to maintain the body in astate of homeostasis, which is a metabolic equilibrium of the bodilyfunctions. However, when this metabolic equilibrium is affected byambient temperature, a hypothalamus set-point for body temperaturerelated reactions may be triggered resulting in decreased blood flow toareas of the body. As blood flow travels farther from the heart andother vital organs, the effect of ambient temperature on the particulararea of the body away from the heart is increased. For example, when theambient temperature is lower than normal, the body will decreaseperipheral blood flow to the extremities in order to maintain thehomeostasis and associated core body temperature of the vital organs.The decreased peripheral blood flow is directly correlated to decreasedperfusion, which leads to a lower skin temperature.

Blood supplies traveling through different areas of the body havedifferent rates of temperature change corresponding to rising andfalling body temperature. The amount of time for fluctuations intemperature to be reflected in the blood supply is largely varied amongthe detection locations on the body. The error or variance is alsoaffected in large part by environmental conditions. Further, each sitehas error variables unique to that site that influence the measurementresult.

Oral temperature is a convenient non-invasive measurement location andis an accepted equivalent for core body temperature, especially inclinical settings. The tongue has a relatively large blood flow with atemperature that mirrors that of core body temperature. However, theactivity of an individual, including coughing, drinking, eating, andtalking, can lower the detected temperature of the individual andproduce an erroneous result. Although widely used, this method oftemperature measurement depends upon proper position of the measuringdevice and cooperation of the patient. Recommended measurement time isthree minutes to get an accurate reading.

Axillary temperature is another convenient and non-invasive site formeasuring temperature. Axillary temperature can be taken externally inthe armpit between two folds of skin of the armpit and arm. The accuracyof this measurement is typically dependent upon the measurement beingtaken relative at a location proximate to the artery on the body side.The axillary site can be adversely affected by ambient temperature inthat an exceptionally cool or warm environment will produce an erroneousresult. Further, the shape of the armpit affects the result because ahollow armpit is less insulated and provides increased exposure toambient temperature of the environment. Temperatures taken in thismanner tend to be 0.3 to 0.4° C. lower than corresponding temperaturestaken orally. The measurement time is similar to the oral temperaturetechnique or longer.

Rectal temperature is measured internally in the rectum. It is the leasttime consuming, with a typical measurement time of one minute. This isparticularly important when measuring the temperature of infants, asthey tend to move around, which causes additional error in themeasurement. It is, however, the most uncomfortable location formeasurement. The increased accuracy over oral and axillary measurementsstems from the fact that the rectum is well insulated from theenvironment and the resulting temperature measurement is a closer matchto an individual's core temperature than the temperatures measured ateither the oral or axillary sites. Temperatures taken rectally tend tobe 0.5 to 0.7° C. higher than corresponding temperature readings takenby mouth.

Although rectal temperature measurements are more accurate, themeasurement process has associated disadvantages. This particular methodposes a risk of injury to the individual because the insertion of thetemperature probe into the rectum may cause perforation of the delicatetissues, in addition to the risk of infections and other illnessesstemming from lack of hygiene relating to the measurement device and/orits use. Also, rectal temperature responds more slowly than oraltemperatures to changes in heat input and loss because any mattercontained within the rectum acts as insulation and any rapid bodytemperature changes are not immediately reflected.

There are two locations in the ear which are also appropriate fortemperature measurement. The first location is the external portion ofthe ear canal. The ear canal is a convenient, non-invasive location butis subject to significant influence by environmental conditions and thecooling effect of these conditions on the body. The second location isthe tympanic membrane which is located deep inside the skull and is notsubject to the same influences as the ear canal. Tympanic temperaturehas also become a common measurement technique in recent years. Tympanictemperature is a close reflection of core body temperature because theeardrum shares the blood supply with the hypothalamus which controlstemperature. Temperature changes are reflected sooner and are moreaccurate. To measure the temperature at the tympanic membrane, however,a long thin thermocouple probe has to be inserted into the ear causing agreat deal of discomfort to the individual. The thermocouple probe mustcontact or at least remain close to the very delicate tympanic membranewhich entails a cooperation of the individual and a risk of injury.

A wide variety of devices and techniques are know for the measurement ofbody temperature, most of which are directed to static, as opposed tocontinuous, measurements. The most accurate devices and methodologiesfor temperature measurement are, unfortunately, the most invasive andinclude pulmonary artery/thermal dilution catheters, esophagealtemperature probes and indwelling bladder and rectal temperature probes.Pulmonary artery/thermal dilution catheters are the most accurate methodof temperature measurement because of the ability to continuouslymonitor the temperature of the pulmonary outflow of the heart. However,because these methods are invasive and impractical, other devices havebeen developed to more conveniently measure the temperature of anindividual, even on a static basis.

The glass mercury or expanding liquid thermometer has been used tomeasure temperature for many years, however the accuracy of this deviceis questionable, in part because its accuracy significantly depends onthe time at which it is properly located and the reader properlyinterpreting the scale. This accuracy deficiency is partially due to thelimited number of locations for measurement while using the device,which include oral, axillary and rectal. Studies have revealed thatglass mercury thermometers demonstrate errors on the order of 0.5° C. or0.9° F. at normal body temperature and errors of greater magnitude whenan individual is febrile. In addition, accidental breakage and disposalis cause for concern when using a glass mercury thermometer. When liquidmercury is spilled, it forms droplets that emit vapors into the airwhich are odorless, colorless and toxic. Because mercury is poisonousand hard to clean up if spilled, these thermometers are less commontoday and have actually been banned in some locations. Also, there is noability of the device to obtain and record a history of the temperaturesof an individual because only individual serial measurements arerecorded on this simple measuring device. Continued long-termtemperature measurement which is not continuous can be troublesome tothe ill individual who must be awake for each measurement. Theelectronic thermometer, also called the digital thermometer, isconsidered more accurate than a glass mercury thermometer, butessentially provides similar functionality with a small improvement inconvenience.

The chemical thermometer, designed to be a one-time use or disposableproduct, is a type of probe thermometer. An example of this type ofthermometer is the Vicks Disposable Thermometer, Model V920. This deviceis a paper device with heat activated chemical dots superimposed on thesurface. The dots change color based on the temperature measurement.This device provides some advantage in that it can be thrown away afterits use so that germs and bacteria do not contaminate the device forcontinued use. However, this particular type of thermometer strip hasbeen found to be imprecise, inaccurate, inconsistent and yields frequentfalse-positive results.

Many of the recent developments in the field of temperature measurementare directed toward improving comfort and convenience for the user, suchas the use of a curved, rubber accessory or probe that is conformed andflexible to fit over the teeth and inside the mouth to rest more easilyon the jaw to garner greater application consistency. These efforts canalso be counterproductive. In one example, a pacifier-like probe isutilized to allow an infant to be monitored with a familiarly shapeddevice. The natural and reflexive sucking action of the infant, however,causes the signal from this device to be noisy and inaccurate. Theseimprovements have therefore been directed toward ease of use issue butlittle has been accomplished in terms of increasing accuracy andconsistency completely apart from technique and user error.Additionally, all of the preceding devices are directed toward staticmeasurements. In most, if not all circumstances, these devices areentirely impractical as continuous temperature monitors for ergonomic,safety, convenience and data retention reasons.

Other newer techniques and devices include sensing diaper urine or bowelmovements in a diaper, immediately after release from the body when thesubstance is at core temperature. The limitation is that this isentirely event driven and must be properly anticipated, in the properlocation, and must be able to detect the peak temperature to record themeasurement before cooling or heating up. Additional practicalconsiderations include the need to dispose of or clean the productbecause the sensor/device is now soiled.

An infrared thermometer is a non-contact temperature measurement devicethat detects infrared energy emitted from an individual and converts theenergy to an electrical signal that can be displayed as a measurement oftemperature after being corrected for variation due to ambienttemperature. An infrared thermometer can be used at a variety oflocations and provide significant advantages. Infrared thermometers canbe used to take temporal membrane measurements which have more recentlybeen reported to have strong correlation to pulmonary arterialtemperature, but have also become popular especially in infantmonitoring because they don't require the measurer to disturb the infantthrough an orifice or under the arm, especially if frequent readings arerequired or prescribed to be performed. The main disadvantage of aninfrared thermometer is that the device is highly dependant on theoperator's technique. It can be difficult to get a consistently accuratereading without a consistent method of use. Also, the cleanliness of theinfrared lens can significantly impact the results of measurement.Further, infrared thermometers typically do not account for the effectsof ambient temperature on the skin temperature measurement of theindividual.

In most cases, there is also the traditional trade off between cost andaccuracy. This is exacerbated in this field, especially within the realmof disposable products. Disposable products are increasingly popular inlight of concerns regarding hygiene. This is most applicable toinstitutional applications. Disposability, however, necessitates a firmcost ceiling for any product, which in turn limits the ability of thedevice to provide more than the most limited functionality.

In many situations, temperature readings, together with the data,diagnoses and other information extrapolated or derived from thetemperature readings, would be more useful and accurate if madecontinuously rather than the periodic, static measurements now commonlymade and described above. Several devices and techniques have beenproposed to facilitate continuous measurement.

Exterior skin has traditionally not been considered an appropriatelocation for temperature measurement, even when measurement is takennear a surface artery. This is, in part, because skin temperaturemeasurements suffer from significant noise from peripheral shutdown,skin insulation, activity and environmental and internal (hydration)convolutions. Even so, skin locations are much less invasive andpotentially comfortable for continuous wear of a temperature monitor.These monitors can also be protected from environmental noises byclothing, diapers, attachable bands and the like.

A Wireless Thermometer manufactured in Taiwan and Japan by Funai andmarketed by Granford Marketing and Management Services under a varietyof trade names provides a transceiver device which is clipped ontoclothing or diaper of the patient to be monitored. A sensor is mountedinternal to the clip and is intended for direct contact with the skin.The device relies upon the article of clothing or diaper to maintain thecontact between the skin and the sensor. The sensor records thetemperature and displays the reading on an LCD screen. The transceiverdevice is paired to a receiver unit by wireless transmission whichreceives the temperature data and may be preset to sound an alarm if acertain temperature threshold is reached. No provision is made forstorage of any historical data. A number of other prior art devices doprovide this functionality.

Rubinstein, U.S. Pat. No. 6,852,085, issued Feb. 8, 2005, for a FeverAlarm System, discloses a continuous body temperature measurementdevice. The device comprises a microprocessor having two thermistorsthat continuously measure skin temperature and ambient room temperaturefor calculation of body temperature. One thermistor lies adjacent to theskin and is insulated from the surrounding environment. The secondthermistor is exposed to the ambient room air and is not in contact withthe skin. The device measures both skin and ambient room temperature andthen transmits the calculated result through an RF transmitter to adisplay unit which displays the current temperature of the individual.The device further includes an adjustable alarm that is triggered when acertain predetermined temperature threshold is reached.

The device continuously measures both skin temperature and ambienttemperature, and must first log a history of ambient room temperaturefor thirty minutes before a first result is calculated. The thirtyminute delay in accounting for the ambient room temperature can belife-threatening when monitoring a febrile individual. The output of thedevice is a calculation, which is not based on the actual measurementhistory of the individual's detected temperature or on a correlation tothat specific individual's physiology, physiological performance,activity and core temperature. Instead, the device obtains thisinformation from programmable read-only memory containing tabular dataof analytic values. The tabular data is derived by a process of data todata mapping in which a particular output is generated for a particularset of possible inputs. The data contained in these look-up tables istaken from previously determined experimental data of body temperatureversus skin and ambient temperature and the relationship and effect oneach other over time. The data requires an initial storage of referencevalues and has no relationship to the input for a specific individual.

Pompeii, United States Patent Publication No. 2003/0169800, for anAmbient and Perfusion Normalized Temperature Detector, published Sep.11, 2003, discloses an infrared thermometer that estimates core bodytemperature by measuring the axillary and/or tympanic temperature ofadults with an infrared sensor. The device calculates core bodytemperature using the arterial heat balance equation which is based onheat flow through thermal resistance from an arterial core temperatureto a location of temperature measurement to the ambient temperature. Thearterial core temperature is calculated based on ambient temperature andsensed skin temperature. Pompeii suffers from the deficiencies describedabove with respect to infrared thermometers, generally, includingtechnique and lens quality. In addition, Pompeii's calculation does notuse a direct measurement of ambient temperature. Ambient temperature isan important factor in determining skin surface temperature because theeffects of ambient temperature on the skin can grossly affect theresulting measured skin temperature. To account for ambient temperature,Pompeii calculates the core temperature of the individual using thesensed temperature of the detector as the ambient temperature, with 80°F. being the presumed value for the detector. However, the detector maybe either cooler or warmer than the surrounding ambient environment,affecting the accuracy of the result of the calculation. The accuracy ofthe final temperature calculation may be improved through adding orsubtracting 20% of the difference between 80° F. and the actualtemperature of the device.

Specifically, in other methods of axillary thermometry, the differencebetween skin temperature and ambient temperature is calculated as beinga weighted coefficient determined by approximating h/pc where h is anempirically determined coefficient which includes a radiation viewfactor between the skin tissue and the ambient temperature, p is theperfusion rate and c is blood specific heat. The approximation of h/pcunder normal circumstances for afebrile individuals varies over a rangeof at least 0.09 to 0.13 corresponding to a variation of about 30%.Instead of assuming that the ambient temperature, estimated by Pompeiito average approximately 80° F., is always the same as the detectortemperature, Pompeii weights the sensor temperature by 20% as the sensortemperature varies from 80° F. For example, if the detector is sensed tobe at 80° F., the corresponding ambient temperature used in thecalculation is not corrected because the detector temperature and theambient temperature are assumed to be equal. However, as the temperatureof the sensor increases or decreases from 80° F., the ambienttemperature used in the calculation of body temperature is varied by 20%accordingly in the same direction.

Fraden, United States Publication No. US 2005/0043631, for a MedicalBody Core Thermometer, published Feb. 24, 2005, discloses a deviceintended primarily for surface temperature measurements. The devicecalculates core temperature by sensing the temperature of the skin whileaccounting for the sensor temperature and ambient temperature. Thedevice has a first sensor for measuring skin temperature as a functionof the thermal resistance of the user. The device has a second sensorwhich measures a reference temperature of the measuring device. AlthoughFraden accounts for ambient temperature, the device is not adapted tomeasure ambient temperature which is an important factor in calculatingan accurate measurement of skin surface temperature. Fraden attempts toeliminate ambient temperature from the calculation by using apre-warming technique comprising an embedded heater to heat the deviceto a temperature that is near the potential skin temperature.

Fraden further utilizes an equation that requires multiple measurementsof skin temperature to account for the effects of ambient temperature.The equation does not require a detected ambient temperature, nor doesFraden measure the ambient temperature. The Fraden device does requireat least three temperature measurements to determine skin temperature.The first measurement is the detected temperature of the device beforeit is placed in contact with the skin. The second measurement is aninitial skin temperature measurement detected upon the placement of theprobe on the skin of the user. The third measurement is the detectedtemperature corresponding to an altered temperature after the device isplaced in contact with the skin. This altered temperature measurement isrelated to the increased skin perfusion resulting from the surfacepressure exerted on the skin by the device. Specifically, when surfacepressure is exerted on the skin of an individual, the perfusion of thestressed skin is increased due to the vasodilatation of the bloodvessels at that particular site. This results in an increased blood flowat the site and possibly a more accurate skin temperature measurement.

Based on the multiple measurements taken with the Fraden device, theskin temperature of the individual is calculated. Core body temperatureis calculated using experimentally determined constants and thecalculated skin temperature. Although the blood flow to the area isincreased so that skin temperature can be more accurately measured,ambient temperature still has an effect on the skin temperature, and theresult of the calculation is in conflict with the true core bodytemperature of the individual.

Matsumura, U.S. Pat. No. 5,050,612, for a Device for Computer-AssistedMonitoring of the Body, issued Sep. 24, 1991, discloses a method forestimating core body temperature at the skin surface comprisingmonitoring the skin surface temperature at a location on the body.Matsumura discloses that ambient temperature affects the temperaturemeasured at the skin surface, but a first device contemplated byMatsumura uses only a skin temperature sensor and insulation to preventthe ambient temperature from affecting the skin temperature measurement.Insulation of at least a four square centimeter area is used inconnection with a temperature sensing means to insulate the skin fromthe surrounding environment such that the skin could theoreticallyadjust more closely to core body temperature. Matsumura furtherdiscloses a second device that includes a second sensor for measuringthe temperature of the ambient environment and in addition to lesserquantities of insulating material to insulate the skin from the ambientenvironment. However, the insulating material is required in a lesserquantity.

Data is detected by both the first and second sensors and used tomanually calculate the core body temperature of the individual. The usercreates a look-up table by charting a record of the skin temperature andcorresponding ambient temperature. Matsumura states that by correlatingskin temperature as it exists at a particular ambient temperature, coretemperature can be determined. Matsumura does not disclose how core bodytemperature is determined but allows for the use of a table to correlatemeasured and calculated temperature. The determination of ambienttemperature can also be affected by the amount of insulation used inconstructing the device. For the first device, Matsumura requires aminimum of four square centimeters of insulation to be placed around thesensor to shield it from the environment. For the second device that isequipped with an ambient sensor, Matsumura is not specific but onlystates that that the required insulation is less than what is requiredfor the first device. If wear of the device is not consistent in thatthe insulation is removed and changed during the charting of referencetemperatures, the effect of the ambient temperature may not be aconsistent result with respect to skin temperature. The insulationshields the skin sensor from the environment and a certain temperatureis detected based upon the amount of insulation used. If the amount ofinsulation varies between the placement of the sensor device on thebody, the accuracy of the user created chart is affected.

Ward, U.S. Pat. No. 4,509,531, issued Apr. 9, 1985 for a PersonalPhysiological Monitor, discloses a continuous physiological monitor thatdetects changes in either galvanic skin resistance, temperature or bothin order to detect the onset of hypoglycemic states in a diabeticindividual. A temperature reference is automatically established by thedevice as it is worn by the user. The skin temperature of the user ismonitored by a skin temperature sensor, and once the measuredtemperature drops below the temperature reference, an alarm sounds. Wardmentions that ambient temperature affects the skin temperaturemeasurements of an individual but does not provide a means to measure ora method to account for ambient temperature.

Dogre Cuevas, U.S. Pat. No. 5,938,619 for an Infant External TemperatureMonitoring Transmitter Apparatus with Remotely Positionable ReceiverAlarm Mechanism, issued Aug. 17, 1999, also discloses a device to detectchanges in skin temperature. However, although the device comprises askin temperature sensor, it does not provide a mechanism to measureambient temperature. Further, Dogre Cuevas does not contemplate ambienttemperature as having an effect on skin temperature.[[.]]

Continuously measuring body temperature of an individual can bebeneficial in monitoring the well-being of that individual and providesa better indication of the individual's normal body temperature. Havingknowledge of the normal body temperature of an individual may aid in theprevention of life-threatening conditions can be prevented or detectedquickly. Temperature measurement devices exist that provide both serialand continuous temperature detection and measurement of the user.However, the serial temperature measuring devices are not very helpfulin monitoring the normal body temperature of an individual for quickidentification of an abnormal temperature unless monitoring is donemanually by the user or caregiver. Further, the current temperaturemeasurement devices that provide continuous measurement provide lessthan accurate results because the devices fail to account for conditionsthat affect skin temperature, including activity, personal physiologyand diaper conditions for both infants and adults.

Additionally, many prior art devices base the calculations of coretemperature upon certain measured alternative conditions, such as skintemperature and utilize standardized conversions or tables of data tocorrelate these readings to a meaningful output temperature.

Therefore, what is lacking in the art is a continuous temperaturemeasurement monitoring device that promotes long term wear and providesan accurate measurement of the actual core body temperature of anindividual. Additionally, what is lacking is a multisensor device whichmay utilize additional environmental and physiological parameters toincrease the accuracy of the temperature output. These temperaturemeasurements may also be utilized to provide activity and conditionalinformation about the individual which may be useful for informational,diagnostic and other purposes.

SUMMARY

A monitoring system is provided which may comprise either a one or amulti component embodiment which includes at least a temperature module.The module may be provided with a display for output of temperature andother data as well as a variety of input capabilities. The module isparticularly sized and shaped to conform to and interface with the skinof the wearer, typically in one of several preselected preferredlocations. The first and most preferred location for the device is inthe valley formed by the juncture of the leg and the torso which isadjacent the passage of the femoral artery close to the hip and ispreferably affixed by the use of an adhesive strip. The module may alsobe affixed to a garment or diaper, but is preferably operated in aconfined space within a diaper or clothing. All applications andembodiments described herein are equally applicable to children andadults, while infants and the elderly or infirm are the most typicalcandidates.

A multi component system includes a module in addition to a receiver forreceiving temperature and other data measurements. The presentation ofraw or derived information may include current skin and/or ambienttemperature, current derived core body temperature, temperature trendsfor all of these current values and contextual data.

Data may be collected and processed by the module and transmitted to areceiver, or may provide all processing on board. The module may also beadapted to communicate with other devices through directtelecommunication or other wireless communication as well as over local,wide area or global computer networks.

The module may be provided with an electronic tag or other ID of someknown type so that receivers may be able to detect and display discreteinformation for each such patient in a multiuser environment. Themodules may also communicate with certain third party or otherassociated devices.

The system is primarily intended for home use, typically for monitoringof an infant. The system is equally applicable, however, to hospital,nursing home or other institutional use. For example, a simple adhesivepatch embodiment may be utilized in an emergency room for each patient,especially those waiting to be seen for the first time, to make initialphysiological assessments or to alert triage about a significant changein the condition of a waiting patient. The module may also be utilizedduring surgery as a less invasive and more convenient temperature orconditional measurement device, especially when other typical locationsfor such measurements are inaccessible or inconvenient. Post operativecare, including the use of temperature dependent patient warming devicesmay also be based upon the output of the system.

The core embodiment of the shape and housing of the module provides asignificant aspect of the functionality of the device. In general, thedevice has a curved, relatively thin housing which may have a variety ofconvex and concave portions for creating an appropriate space andinterface with the skin. It is typically held in place by an adhesivepad, which may be shaped in accordance with the needs of the specificapplication. The adhesive material may further support or contain all oradditional sensors or electrodes for detection of the variousparameters.

The housing components of the module are preferably constructed from aflexible urethane or another hypoallergenic, non-irritating elastomericmaterial such as polyurethane, rubber or a rubber-silicone blend, by amolding process, although the housing components may also be constructedfrom a rigid plastic material. An ambient temperature sensor ispreferably located on the upper surface of the housing facing away fromthe skin and a skin temperature sensor is preferably located along aprotrusion from the lower housing and is placed against the skin. Thehousing may be provided with an orifice therethrough to facilitate theuse of heat flux sensors thereon.

While the preferred embodiment is durable in nature, a number ofdisposable or combination embodiments are presented. In disposableapplications, the entire module and mounting material are utilized for arelatively short period of time and are discarded. In a combinationembodiment, certain key or costly components are placed in a durablehousing which is integrated physically and electrically with additionalcomponents which are disposable. Disposable and combination embodimentsare specifically directed at short term use and low cost. Certainembodiments may be specifically provided with a known, limited lifetime.

In all embodiments, a number of methodologies are described forinitiating operation of the device. The device and attendant receivermay have traditional means for turning the units on or off, or may beauto-sensing, in that the devices wake up upon detecting certainuse-related conditions. The devices may also be equipped with medicationor other nutrients or the like for delivery by the device, uponprogrammed control or direction by a caregiver.

A receiver is intended to display a variety of information and may beincorporated in other devices such as a clock radio which has a primaryuse unrelated to the temperature measurement system. The receiverprovides a locus of information relating to the changing condition ofthe wearer and may present an iconic, analog or digital indication as tothe data being measured, any derived information based upon bothmeasured and other data as well as certain contextual information. Alsodisplayed may be trends of change and indications of changes meetingcertain present thresholds. Alarms, warnings and messages, both on thereceiver and sent through the various transmission networks may beinitiated upon the meeting of such preselected or event driventhresholds.

The module includes at least one sensor, a processor and potentially anamplifier to provide appropriate signal strength of the output of thesensor to the processor. An analog to digital converter may also beutilized. The digital signal or signals representing detectedtemperature data and/or other relevant information of the individualuser is then utilized by the processor to calculate or generate currenttemperature data and temperature data trends as well as derived data andcontextual data. All data or relevant information may be stored inmemory, which can be flash memory. A discrete clock circuit may also beprovided. Sensor input channels may also be multiplexed as necessary.The processor may be programmed and/or otherwise adapted to include theutilities and algorithms necessary to create derived temperature andother related data. The receiver may output the data directly on adisplay or other informative means to a caregiver or may transmit thedata according to a number of techniques electronically to a network orother device.

In operation, the skin temperature sensor preferably detects a skintemperature and an ambient temperature sensor preferably detects atemperature corresponding to the near ambient environment of theindividual within the protective enclosure of the diaper. The module issubject to calibration to aid in the accuracy of the detection of data.The step of feature creation takes as input the temperature data or anyother sensor data, which may or may not comprise calibrated signals andproduces new combinations or manipulations of these signals. The systemreviews and analyzes the data streams and identifies patterns andconditions, preferably through the use of multiple sensors. Thesedetectable patterns and conditions, together with conditions andparameters which are observed immediately prior to such patterns andconditions, create repeatable and definable signals which may beutilized to warn or predict future events, behavior or conditions. Thisdata and conclusions may be presented in graphs, reports or other outputwhich reflect the correlations and predictions.

The device is also able to detect appropriate data to derive theproximity of other humans to the patient as mentioned above. Additionalmodalities for detection of proximity include those well known in theart as well as a proximity detector, as disclosed herein, which utilizesan oscillator constructed around the ambient capacitance of a metalplate. As the environment surrounding the plate changes, such asmounting the device on the human body or moving other objectscloser/farther from the device, the capacitance of the plate changes,leading to a change in the frequency of the oscillator. The output ofthe oscillator is then input into a counter/timer of a processor. Thispermits the device to be aware and detect the presence of humans orother defined objects, which may be recorded and utilized as part of theanalytical tools identified above.

The device may preferably be utilized for (i) monitoring of infants andchildren in day care or other extended non-parental supervision and (ii)the increasingly important monitoring of elderly patients underinstitutional or other nursing care, in order to detect or assess, amongother things, abuse and neglect of the people under care.

BRIEF DESCRIPTION OF THE FIGURES

The invention and the following detailed description of certainembodiments thereof may be understood by reference to the followingfigures:

FIG. 1 is a diagrammatic representation of a system utilizing thetemperature measurement module together with various embodiments of areceiver device.

FIG. 2A is a top plan view of a core leaf spring embodiment of atemperature measurement module.

FIG. 2B is a side elevational view of a core leaf spring embodiment of atemperature measurement module.

FIG. 2C is an end elevational view of a core leaf spring embodiment of atemperature measurement module.

FIG. 2D is a bottom plan view of a core leaf spring embodiment of atemperature measurement module.

FIG. 3 is an alternative embodiment of the core leaf spring embodimentof a temperature measurement module.

FIG. 4 is a cross sectional view of a of a temperature measurementmodule mounted on the body of an individual.

FIG. 5A is an isometric view of the top surface of a preferredembodiment of a temperature measurement module.

FIG. 5B is an isometric view of the bottom of a preferred embodiment ofa temperature measurement module.

FIG. 5C is a top plan view of a second embodiment of a temperaturemeasurement module.

FIG. 6 is an exploded view of the preferred embodiment of thetemperature measurement module.

FIG. 7A is an isometric view of the top of a exploded bottom view of athird embodiment of the temperature measurement module.

FIG. 7B is a sectional view of the third embodiment of the temperaturemeasurement module.

FIG. 7C is a top plan view of an adhesive strip for mounting the thirdembodiment of the temperature measurement module to the body.

FIG. 8 is an exploded view of a fourth embodiment of the temperaturemeasurement module.

FIG. 9 is a top plan view of three aspects of a fifth embodiment of thetemperature measurement module with a detachable handle.[[.]]

FIG. 10 is an isometric view of a sixth embodiment of the temperaturemeasurement module.

FIGS. 11A-G illustrate five aspects of a seventh embodiment of thetemperature measurement module.

FIG. 12 is an eighth embodiment of the temperature measurement module.

FIG. 13 is a ninth embodiment of the temperature measurement module.

FIG. 14 is a tenth embodiment of the temperature measurement module.

FIG. 15 is an eleventh embodiment of the temperature measurement module.

FIG. 16 is a diagrammatic representation of a first embodiment of areceiver.

FIG. 17 is a diagrammatic representation of a receiver display.

FIGS. 18A-C are additional diagrammatic representations of a receiverdisplay.

FIG. 19 is a diagrammatic view of a first embodiment of the circuitry ofthe temperature measurement module.

FIG. 20 is a diagrammatic view of a second embodiment of the circuitryof the temperature measurement module.

FIGS. 21A and 21B are diagrammatic views of a third embodiment of thecircuitry of the temperature measurement module including a receiver.

FIG. 22 is a logic diagram illustrating the operation of the temperaturemeasurement module.

FIG. 23 is a graphical representation of output of the temperaturemeasurement module.

FIG. 23A is a graphical representation of output of the temperaturemeasurement module.

FIG. 23B is a graphical representation of output of the temperaturemeasurement module.

FIG. 24 is a diagrammatical representation of an aspect of the logicutilized in the operation of the temperature measurement module.

FIG. 24A is a diagrammatical representation of an aspect of the logicutilized in the operation of the temperature measurement module.

FIG. 25 is a diagrammatical representation of an aspect of the logicutilized in the operation of the temperature measurement module.

FIG. 26 is a graphical representation of output of the temperaturemeasurement module.

FIG. 27 is a graphical representation of output of the temperaturemeasurement module.

FIGS. 28A and 28B are graphical representations of output of thetemperature measurement module.

FIG. 29 is a graphical representation of output of the temperaturemeasurement module.

FIG. 30 is a graphical representation of output of the temperaturemeasurement module.

FIG. 31 is a graphical representation of output of the temperaturemeasurement module.

FIG. 32 is a graphical representation of output of the temperaturemeasurement module.

FIG. 33 is a graphical representation of output of the temperaturemeasurement module.

FIG. 34 is a graphical representation of output of the temperaturemeasurement module.

DETAILED DESCRIPTION

With reference to FIG. 1, the monitoring system may comprise either aone or a multi component embodiment. In its simplest form, being a onecomponent embodiment, temperature module 55 is provided with display 86Afor output of temperature and other data. Module 55 may be provided,according to the knowledge of one skilled in the art, with a variety ofinput capabilities, including wired or wireless transmission in a mannersimilar to the wireless output described herein. Other modalities ofinput may include a button, dial or other manipulative on the deviceitself (not shown). This one component embodiment is placed immediatelyadjacent to and in contact with the body of an individual at one of manypreselected locations as will be described further. It is to bespecifically noted that each module may also be generally comprised ofthe features and components of those sensor units described in:Stivoric, et al., U.S. Pat. No. 6,527,711, issued Mar. 4, 2003, forWearable Human Physiological Data Sensors and Reporting System Therefor;Stivoric, et al., U.S. Pat. No. 6,595,929, issued Jul. 22, 2003, forSystem for Monitoring Health, Wellness an Fitness having a Method andApparatus for Improved Measurement of Heat Flow; Teller, et al., U.S.Pat. No. 6,605,038, issued Aug. 12, 2003, for System for MonitoringHealth, Wellness and Fitness; Teller, et al., pending U.S. patentapplication Ser. No. 09/595,660, for System for Monitoring Health,Wellness and Fitness; Teller, et al., pending U.S. patent applicationSer. No. 09/923,181, for System for Monitoring Health, Wellness andFitness; Stivoric, et al., pending U.S. patent application Ser. No.10/227,575, for Apparatus for Detecting Human Physiological andContextual Information; Teller, et al., pending U.S. patent applicationSer. No. 10/682,759, for Apparatus for Detecting, Receiving, Derivingand Displaying Human Physiological and Contextual Information; Andre, etal., pending U.S. patent application Ser. No. 10/682,293, for Method andApparatus for Auto-Journaling of Continuous or Discrete Body StatesUtilizing Physiological and/or Contextual Parameters; Stivoric, et al.,pending U.S. patent application Ser. No. 10/940,889, for Method andApparatus for Measuring Heart Related Parameters and Stivoric, et al.,pending U.S. patent application Ser. No. 10/940,214 for System forMonitoring and Managing Body Weight and Other Physiological ConditionsIncluding Iterative and Personalized Planning, Intervention andReporting, which are all incorporated herein by reference.

In the one component embodiment, all functions including data output arecontained within the housing of temperature module 55. While almost anycontact with the body is sufficient to enable the user to develop someindication of temperature, in the most preferred forms, temperaturemodule 55 is placed in one of the preselected locations. This placementis applicable to both the one and multi-part component embodiments.

Referring to FIG. 1, module 55 has multiple alternative placementlocations and is positioned adjacent to and in contact with the wearer'sbody. The first and most preferred location for the device is in thevalley formed by the juncture of the leg and the torso which is adjacentthe passage of the femoral artery close to the hip. This femoral regionprovides a location which is well sheltered from body movements whichmight lead to dislodgement, is close to a major blood vessel at or nearcore temperature and the skin surrounding the area is conducive tomounting module 55. Other mounting locations include the inguinal area,the axillary area under the arm, the upper arm, the inside of the thigh,crotch/groin area, behind the ear and ear lobe, the forehead, inconjunction with the tympanic location described above, on the sole ofthe foot, the palm of the hand, the fingers, the wrist, between thecorner of an eye and the side of the nose, the chest and on the back inseveral locations along the spine. Generally, appropriate locations arethose locations as where module 55 is amenable to the use of clothing orskin or both as an insulating structure and/or environmentallyprotecting, which improves the accuracy of the skin, which is wellperfused in these areas. Additionally, an important consideration is theability to obtain an appropriate ambient temperature, as will bedescribed more fully herein, at that location. With particular referenceto the back regions, especially in infants or bedridden adults,particular advantage can be taken of the insulation features of themattress upon which the infant is sleeping to the body. This minimizesexternal influences and noise. Additionally, any moving, rolling over orsitting upright by the child will result in alternative readings whichcan be useful in determining whether the context and/or position of thechild has changed, as will be more fully described herein. Lastly, otherphysiological parameters, such as heart beat, energy expenditure and thelike can be measured at many of these locations, as more fully describedin Stivoric, et al., U.S. patent application Ser. No. 10/940,889.

Although an infant is illustrated in FIG. 1, all applications andembodiments described herein are equally applicable to children andadults. Furthermore, the use of different types of garments, includingdiaper 60 are to be considered analogous in infants, children andadults. With respect to the femoral region location, it has beenobserved that infants, especially prior to full development of internaltemperature regulation systems, may exhibit excellent correlation tocore temperature at the skin. After development of temperatureregulation in the older infant, child or adult, this location providesexcellent correlation to core temperature at the skin, however, certainadaptations to measuring devices and techniques must be adopted, whichwill be more fully described herein, in order to ensure proper skinperfusion, insulate the skin temperature sensor from the ambientenvironment and potentially utilize other sensor readings to adjust thedetected measurements.

It is generally considered in the art that the skin is one of the leastaccurate sites to measure for core temperature. It is, however,considered a useful adjunct to other standard temperature methods,especially for evaluations of how environmental, physiological and/orphysical activity affects human body. Accuracy is significantly affectedby perfusion characteristics of the skin and tissue immediately adjacentthe measurement location. One additional location for temperaturemeasurement is the wrist, however, it must be understood that this areais plagued by very significant and complex noise because of peripheralshutdown of the arterial and venous systems, as well as increasedactivity levels at this location.

It is further contemplated that a multiplicity of modules 55 may beplaced on the body simultaneously to increase accuracy of detectedparameters and derived output. Additionally, each one of such multiplemodules may have different sensors or capabilities, with the data fromeach being transmitted to another module having the appropriateprocessing on board, or to an off-body receiver which collects andprocesses the data from the various modules. Moreover, some processingcan be performed on some modules and not others, as necessary totransmit the data in a useful manner.

As will be discussed further herein, the temperature module 55 ispreferably operated in a confined space, such as within a diaper orclothing. This confined space serves to filter ambient noises that canaffect the skin temperature readings. In certain embodiments, however,module 55 may be utilized to detect certain physiological parameters,such as activity, which may be improved by the exposure of portions ofthe device to ambient conditions. The confined space, in the appropriateembodiments, may also be provided as part of an adhesive patch ratherthan under clothing or a diaper.

A multi component system includes module 55 that may be provided withdisplay 86A, in addition to a receiver for receiving continuoustemperature measurements and other relevant, statistical data includingprocessed data that is output from module 55 for visual presentation ondisplay 86A of module 55 or on a receiver display 86B The visualpresentation of information may include current skin and/or ambienttemperature, current derived core body temperature, temperature trendsfor all of these current values, and contextual data, Contextual data asused herein means data relating to the environment, surroundings,location and condition of the individual, including, but not limited to,air quality, audio sound quality, ambient temperature, ambient light,global positioning, humidity, altitude, barometric pressure and thelike. It is specifically contemplated, however, that contextual data mayalso include further abstractions and derivations regarding thecondition and status of the body, including the position of the body andthe detection of certain events and conditions within and without thebody, such as urination in a diaper, dislodgement of the module,activity and rest periods, the nature and quality of sleep and removalof the insulating clothing or diaper.

Module 55 may further be integrated into an item of clothing or adiaper, subject to the requirements, as more fully described herein,that sufficient pressure is exerted on the module in order to achieveproper interface with the skin.

Data may be collected and processed by module 55 and transmitted byprimary transmission 72 to a receiver through a short range wirelesstransmission, such as infrared, RF transmission or any other knownwireless transmission system as known to those skilled in the art and asfurther described herein with respect to FIGS. 19-21. The receiver cantake one of a number of forms, including a table top receiver 85, a handheld receiver 65, clinical monitor receiver 70, a personal computer 75or a necklace receiver 80, a ring, a headworn display, a headsupdisplay, a display built into the dashboard or windshield of a car,displayed directly on the clothing of the person being monitored or onthe caregiver's clothing, displayed on household appliances such as arefrigerator, a microwave oven or conventional oven, be reflectedqualitatively in controllable ambient conditions such as the temperatureof a room, the lighting of the room, or the sound in a room, a watch oran armband as disclosed in Stivoric, et al., copending U.S. patentapplication Ser. No. 09/923,181 and can be remotely positionable withrespect to module 55. The receiver may further comprise a microphone, aswould be apparent to one skilled in the art, for detecting environmentalsounds. The distance between module 55 and receiver is dependant uponthe type of transmission used. The module may also be provided with awide area wireless chip or other CDMA equivalent for directtelecommunication with other devices or through a network. The modulemay also transmit its data to such a chip in a cell phone or otherdevice that includes wide area wireless functionality, which may thenforward the information anywhere in the world. Alternatively, module 55may communicate with a receiver or a group of receivers that combinesthe features of any one of the receiver forms. If more than one receiverunit is utilized in a multi-component system, the data is relayed acrossthe network of transceiving components or transmitted to each receiverin the system as described more fully with respect to FIGS. 19-21.

It is further contemplated that intermediate receivers may be utilizedto both expand the range of the system as well as provide another locusfor processing capability. In this embodiment, a primary transmission 72would be provided between a receiver 85 and module 55, and a secondarytransmission 73 would be provided between the receiver 85 and anadditional receiver, such as personal computer 75. Additionally, in amultisensor, multipatient environment, module 55 may be provided with anelectronic tag or ID of some known type so that receivers may be able todetect and display discrete information for each such patient. Themodules may also communicate with certain third party or otherassociated devices which may be associated with the wearer or evenimplanted thereon, such as a false tooth or therein to uniquely identifythat wearer by electronic or biofingerprinting means. Additionalreceivers and multiple levels of transmission are contemplated in suchan environment with appropriate encoding or transmission identificationto prevent overlap or confusion of signals. It is also possible to adapta mass triage system such as that described in Stivoric, et al.,copending U.S. patent application Ser. No. 10/940,889 which would alsoallow communication to occur across modules near each other as aself-healing network which is also location-awareness capable.

Table top receiver 85 is provided with a housing that containselectrical circuitry for communicating with module 55 and receiving therelevant data, as described further herein with respect to FIGS. 19-21.Table top receiver 85 may be battery-operated; self powered through heatflux, magnetic flux, solar power, motion flux or ambient RF harvestingor it may operate through a power supply by inserting an attached pluginto an electrical outlet. Receiver may be in the form of a hand-heldreceiver 65 which is also preferably constructed of a rigid plastic,although the housing may also be constructed from any durable,disposable, or biodegradable material that can protect the components ofhand-held receiver 65 from destruction and/or the necessary times ofuse. Clinical monitor receiver 70 operates in a likewise manner as theother receivers and is utilized in a medical setting. Necklace receiver80 is constructed of a lightweight material conducive to being worn onthe body or may be in the form of a key fob, a ring, a bracelet, or thelike.

Clinical monitor receiver 70 and personal computer 75 receive continuousraw and derived temperature measurements and other related data,including processed data such as current temperature, temperature trendsand contextual data from module 55. Clinical monitor receiver 70 andpersonal computer 75 may further include a processor to processcontinuous temperature and other related data and calculate currenttemperature, temperature trends and contextual data. Clinical monitorreceiver 70 may contains additional features so that it can beelectrically connected to third-party medical monitoring equipment whichis used to monitor other patient conditions. These receivers may be usedfor additional purposes, which may, in fact, be the primary purpose forwhich the device is designed.

Any of the receivers is adapted to receive continuous temperaturemeasurements and other related data, including processed data such ascurrent temperature, temperature trends, patterns recognized, derivedstates and contextual data from module 55, as will be more fullydescribed herein. Each receiver is adapted to display relevant data ondisplay 86B according to the process described with references to FIGS.19-21 herein.

Module 55 may also be provided with the ability to obtain data, eitherthrough a wired or wireless connection, from other types ofphysiological detection equipment, such as a glucometer or ECG device,incorporate that data into its detected parameters and/or process and/ortransmit the combined and collected data to the receiver. The device canalso be provided with anti-tamper mechanisms or features to prevent orat least identify whether it has been opened or manipulated. This isalso applicable to any covering or adhesive material utilized to mountthe module to the body. The module could also be provided withmedication which could be administered subcutaneously or topically uponthe receipt of the necessary instructions.

FIG. 2A illustrates a core embodiment of the shape and housing of module55, which provides a significant aspect of the functionality of thedevice. The figures are intended to illustrate the central surfacefeatures of the primary embodiments, regardless of overall geometry andare generally applicable thereto. A leaf spring module 230 is preferablyconstructed of a flexible or springy material having a durometer between80 A and 90 A, however the module performs equally well as a rigiddevice. FIGS. 2A through 2D are intended to illustrate the grossphysical features of the device. Leaf spring module 230 has upperhousing 95, a first long side 240, a second long side 245, a first shortside 250 and a second short side 255 with the first and second longsides 240, 245 having a curved shape. It is to be noted that secondshort side 255 may be smaller in section than first short side 250, asillustrated in FIGS. 2A through 2D to facilitate mounting in certainareas of the body, including the femoral region. The module is generallyconcave on upper housing 95 in the longitudinal central section 243along the longitudinal axis extending from short sides 250, 255 and maybe flat, convex or a combination thereof, as well as along transversecentral section 244 extending from long sides 240, 245. It is furtherprovided with longitudinally convex features 246 at the distal ends ofupper housing 95. These features 246 may be flat, convex or concave or acombination thereof in the transverse direction.

Additionally, the first long side 240 and second long side 245 arepreferably chamfered or radiused, as would be selected by one skilled inthe art, along the edges that form the boundaries connecting a sidesurface 260 of leaf spring module 230 to lower housing 100 and along theboundaries connecting side surface 260 of leaf spring module 230 toupper housing 95. The chamfered edges of first and second long side 240,245 allow the skin to form around leaf spring module 230 as it ispressed against the body, rocking along with the body's motions, whilemaintaining sensor contact. This chamfered surface is furtherillustrated with respect to FIG. 6C. The chamfered surface may be flat,convex, or slightly concave or some combination through its crosssection and along the length of the chamfer.

Lower housing 100 is generally convex in both longitudinal centralsection 243 and transverse central section 244. However, the convexityof transverse central section 244 may alternatively be formed by threerelatively flat longitudinal regions 247, 248, 249, separated by ridges.Central longitudinal region 248 may not necessarily extend entirelybetween short sides 250, 255 but may be confined to a central region.

As shown in FIGS. 2A-2D, the shape of leaf spring module 230 isgenerally curved so that lower housing 100 is in contact with the bodyof the wearer. The curvature of leaf spring module 230, as illustratedin FIG. 2B, causes lower housing 100 to exert pressure on the skinsurface of the wearer which results in increased contact of wearer'sbody with lower housing 100 in addition to increased perfusion of theskin. This interaction creates a snug and relatively insulated interfacebetween the skin and module, especially in the central longitudinalregion 248 within longitudinal central section 243, which increases, orat least leaves undisturbed, the perfusion of the skin beneath themodule with fresh blood which is relatively close to core temperature.This interface is further facilitated by the folding of adjacent skinalong the sides of the module which may also overlap the module to thelevel of upper housing 95 and cradle the module therein. The locationsselected and identified herein for placement of the module are generallyconcave to accept the convex form of the module, or are pliant enough tobe molded into the appropriate shape to accept the module and create thenecessary interface. With respect to the folds of skin coming in contactwith the surface or edge, the radiused or chamfered edges are designedto not impinge on comfort and the convex curves and chamfers arespecifically intended to push into the cavities available at thelocation, especially with limbs and body folds, taking intoconsideration not just the skin surface, but also the muscles adjacentand underneath these regions which allow for these placements and easethe acceptance location and pressure of the module comfortably at thelocation.

The generally curved shape of leaf spring module 230 and chamfered edgesof first and second long side 240, 245 accept, allow, and guide thefolds of the skin, fat, and muscle to comfortably and unobtrusively foldover onto the upper housing 95 of leaf spring module 230. In infantsespecially, the skin fold of the femoral region is convex when theinfant's body is fully extended, however, in its natural state, or fetalposition, the legs are folded toward the torso. This creates a mostlyconcave space for accepting the module and module 55 is adapted forinsertion in this area because of the shape of the leaf spring module230. In addition, the surface of upper housing 95 facing away from thebody is preferably concave, but it can be flat or convex in crosssection, to accept the folds of skin in the femoral region of the body,axillary or other local. The size and dimension of leaf spring module230 does not affect the fit of leaf spring module 230 in the femoralregion. Further, the corners of leaf spring module 230, and optionallyall edges or intersections of surfaces, may also be radiused for comfortand wearability of the user so that the leaf spring module 230 does notirritate the body unnecessarily.

The material from which leaf spring module 230 is constructed can absorbthe shocks of the motions of wearer while maintaining pressure of theskin temperature sensor area of lower housing 100, illustrated in FIG.2D, against the desired contact location. This absorbent quality canadditionally be aided by the use of a stretchable springy adhesive toadhere the module to the body, as will be more fully described herein,especially if the module itself is rigid. The material from which leafspring module 230 is constructed should further have a slight bendingquality yet with sufficient memory which enables the leaf spring module230 to retain its shape over long-term continuous use. Becauseappropriate interface contact of the relevant areas of lower housing 100of leaf spring module 230 with the skin surface of the wearer ismaintained, the results are not substantially affected by wearer motionsincluding bending over, lifting of the leg, and contraction or extensionof the stomach and abdomen muscles. In addition, the generally curvedbody shape of leaf spring module 230 causes it to push into the skin andconform to the body's natural shape allowing it to roll with the bodyand further have a spring action as it moves with the motions and foldsof the body of the wearer.

Leaf spring module 230 is attached to the body by an integrated orseparate adhesive material, the shape and configuration of which will bemore fully described herein. While the application of the appropriateadhesive material will be highly case dependent and within the ambit ofone skilled in the art, a non-exhaustive list of such materialsincludes: hydrophilic material which will allow skin to breathe andtransfer of water or sweat from skin surface; semi permeable films,polyurethane foams, hydrogels; Microfoam, manufactured by 3M Corporationand Tegaderm, also manufactured by 3M. These adhesives could also belayered with a heat-sensitive gel having a lower critical solutiontemperature where under the influence of the user's body or skintemperature, the intermediate layer actively produces a constantmodification of contact points to either enhance or limit or selectivelylimit thermal conductivity and or comfort between the module or adhesivestrip and the skin. The adhesive may further be provided on the moduleitself.

The attachment to the module may also be a non adhesive interface suchas a collar or flexible restraint around the perimeter by stretchingover it or popping over a lip, as more fully described in Stivoric, etal., copending U.S. patent application Ser. No. 10/227,575. The adhesivemay also be variable in its adhesive qualities and not monolithic acrossits surface, different on the module as opposed to the skin interface,and even variable at these different surfaces. A non-woven adhesive,with appropriate breathable materials that provide the stretch andspring to further enable the concept of the leaf spring module's sensorcontact with the body and response to human movements and skin folds,muscle interactivity, and any combination of the above is mostpreferred. Adhesive material is in contact with a portion of leaf springmodule 230 on first short side 250 and extends to skin of wearer.

The adhesive pad may be shaped in accordance with the needs of thespecific application, however, a non-exhaustive list of examples wouldinclude the use of a simple adhesive strip which covered the moduleeither longitudinally or transversely, wings of adhesive material whichextend outwardly from the module itself which may beremovable/replaceable and multiple adhesive sections which hold the endsof the module or have multiple connected sections or snaps which fastenthe module to the skin according to various geometries. The adhesivematerial may further support or contain additional sensors, electrodesfor use in an ECG detector or piezoelectric strain gauges for theadditional sensing capabilities. The module being restrained by theadhesive is also exhibits to certain detectable movement, which may actas a shuttle in an accelerometer. This displacement may then providebasic information regarding activity and motion similar to anaccelerometer.

Leaf spring module 230 can also be held in place on the body by pressurereceived from a waist band or a similar pressure causing object. Forexample, besides adhering to skin, the adhesive could adhere to itself,loop back and adhere to itself and/or loop back and connect to itselfwith a reseatable/removable fastener. Leaf spring module 230 may besnapped into or otherwise held in place in a garment, a waist-band orother like restraint. The module may also be restrained in a tightlyfitting garment which is particularly designed to exert sufficientpressure on the module to create the skin interface. The garment mayhave specific body tension areas which are designed for such function,or elastic or other materials arranged as appropriate. The module can beintegrated into the garment, and simply placed, snapped or pocketedbehind these tension areas, without module required adhesive.

Referring to FIG. 3, leaf spring module 230 may also be detachable orprovided with integrated flexible wings 231 that create downwardpressure or increased stability on the skin when pressed on or adheredto the body to create a compound spring form that moves and bounces withthe body motions while maintaining contact with the skin of the wearer.The pressure contact with the skin reduces signal noise resulting frombody motion and can reduce temperature warm up times.

The dimensions of the leaf spring module 230 are variable depending onthe age of the wearer. Some tested and preferred, but not limiting,dimensions for a larger leaf spring module 230 are 1.325 inches long×2.5inches wide×0.25 inches deep. The dimensions for a smaller size leafspring module 230 further vary based on the age and size of the wearer,and may be 1.5×0.6125×0.25 inches, respectively. The size of leaf springmodule 230 can vary considerably from these dimensions based on thespecific embedded components or additional constraints such as the needto conform to safety regulations as provided in the United StatesConsumer Product Safety Commission, Office of Compliance, Small PartsRegulations, Toys and Products Intended for Use By Children Under 3Years Old, 16 C.F.R. Part 1501 and 1500.50-53.

FIG. 4 illustrates a cross section of module 55 mounted on the body ofthe wearer. Module 55 has an ambient temperature sensor 120 locatedalong upper housing 95 of module 55 and a skin temperature sensor 125located along lower housing 100 of module 55. Module 55 optionally hasfoam insulation in contact with and covering a portion of module 55.Foam insulation may be incorporated as outer mounting foam and includesan upper foam support. Upper foam support 305 is in contact with andextends along one end of upper housing 95 of module 55. Additional upperfoam support 305 is in contact with and extends along the opposite endof upper housing 95 of module 55.

Foam insulation, in order to increase the thermal footprint of thedevice and therefore increasing and/or maintaining skin perfusionlevels, may also be incorporated as lower foam support 307. Lower foamsupport 307 is in contact with and extends along one end of lowerhousing 100 of module 55. Additional lower foam support 307 is also incontact with and extends along the opposite end of lower housing 100 ofmodule 55. Foam insulation can be placed at any one of these locationsor in a combination of these locations.

Module 55 is secured by adhesive strips that may be placed at a numberof locations further illustrated in FIG. 4, including an upper adhesive300 and a lower adhesive 298. Upper adhesive 300 extends across module55 on one end of upper housing 95 and is in contact with and coveringupper foam support 305. Upper adhesive 300 may extend beyond upper foamsupport 305 and be in direct contact with upper housing 95 of module 55.

Lower adhesive 298 extends across module 55 on one end of lower housing100 and is in contact with and covering lower foam support 307. Loweradhesive 298 is further in contact with the skin in a manner thatadheres module 55 adjacent to skin 310 for temperature measurement.Lower adhesive 298 may be double-sided adhesive strips (add this to wingconcept) having one side adhered to lower foam support 307 and a secondside adjacent to and in contact with the skin of wearer. Adhesive strips298 and 300 can be shaped for a particular part of the body on whichmodule 55 is located. The adhesive strips are also flexible so thatmodule 55 adheres to the body of the wearer body while the body is inmotion.

FIGS. 5A through 5C illustrate the general construction of a module 55constructed generally in accordance with the description of leaf springmodule 230, accounting for construction and manufacturing considerationsand needs. The housing components of module 55 are preferablyconstructed from a flexible urethane or another hypoallergenic,non-irritating elastomeric material such as polyurethane, rubber or arubber-silicone blend, by a molding process, although the housingcomponents may also be constructed from a rigid plastic material.Ambient temperature sensor 120 is located on upper housing 95 and isprotected by a sensor cover 115. Ambient temperature sensor 120 can belarge enough such that the entire surface of upper housing 95 can be theactive sensor area, or the active sensor can be located only on aportion of upper housing 95, preferably at the apex of upper housing 95furthest from the wearer's body, and skin in order to provide thelargest thermal variance and/or insulation from the skin temp sensor. Itis to be specifically noted, however, that to the extent that module 55is located within a diaper or article of clothing, ambient temperaturesensor 120 is not detecting ambient temperature of the room or even theenvironment near the body. It is detecting the ambient temperature ofthe area enclosed within the article of clothing or the diaper. Ambienttemperature sensors for detection of the actual room temperature or thearea surrounding the area of exposed parts of the body are provided byother ambient sensors, as will be described more fully with respect tomulti-module embodiments or the receiver unit. This enclosed ambienttemperature which is actually sensed by ambient temperature sensor 120in most uses and embodiments is particularly useful in both derivationof the core temperature as well as the context of the user or any eventsoccurring to the user, as will be described herein with respect to theoperation of the system.

As illustrated in FIG. 5B, module 55 further comprises a lower housing100 opposite upper housing 95. Skin temperature sensor 125 is locatedalong protrusion 110 which corresponds to central longitudinal region248 of leaf spring module 230. Lower housing 100 of module 55 is placedadjacent to and in contact with the skin of the wearer. Relievedsections 107 adjacent protrusion 110 correspond to lateral longitudinalregions 247, 249 of leaf spring module 230 and enhance the interface ofprotrusion 110 with the skin. The surface of lower housing 100 ispreferred to be smooth for cleaning requirements especially formulti-use products, but the surface may be textured, either finely orcoarsely, to increase the connection to the wearer's skin irrespectiveof dead skin cells and hair or to increase contact surface area, pushingaround the hair, and upon application and or continued skin movementslight abrading the skin of its dead cells to make a cleaner connection.These surfaces of any can also be enhanced by the use of microneedles togather data that is not as insulated by the cutaneous skin surface,where the microneedles are probing an active, fluid,subcutaneous/epidermal layer of skin. Especially in less durableapplications, such as disposable patches, as described more fullyherein, that are meant for limited use time periods, these microneedlesor other textures could be quite advantageous, where the thermalconduction to the sensor is extended to these forms in order to be lessaffected by the insulated qualities of stratum corneum, extending intothe epidermal layer, not long enough to extend into the blood or nerveending/pain receptors and into an interstitial layer that willpotentially/inherently conduct body temperatures to the sensor betterthan the surface of the skin. The convex surface of module 55, andspecifically protrusion 110 of lower housing 100, enables module 55 topush into the skin and maintain contact with the skin during the variousbody and/or limb positions, activities, conditions or bodily motions andallows module 55 to conform to bodily motion. Conversely, the surfacefeatures guide the skin thickness and folds and underlying muscles toconform around or along the form of the module, maintaining a highdegree of actual and perceptual comfort to the wearer, but alsomaintaining a high degree of contact with the skin of the body, as wellas aiding in the insulation of the sensor from the ambient environmentand temperature.

FIG. 5C illustrates a second embodiment of module 55 which is anelongated module 130. As previously described with respect to FIGS. 5Aand 5B, the housing components of module 130 are preferably constructedfrom a flexible urethane or an elastomeric material such as rubber or arubber-silicone blend by a molding process, although the housingcomponents may also be constructed from a rigid plastic material.Ambient temperature sensor 120 is located along a central portion ofupper housing 95 of elongated module 130 and can be protected by sensorcover 115 if necessary, as described with respect to FIG. 5A. Elongatedmodule 130 further has a first wing portion 131 and a second wingportion 132. Wing portions 131, 132 are located opposite to each otheron either side of sensor cover 115 and can be of equal or varyinglengths and widths depending on location of body being attached torequirements for adhesion and force against the body. Elongated module130 may be adapted to conform to the size of an individual other than aninfant in that the dimensions of the first wing portion 131 and thesecond wing portion 132 can be varied. Depending on certaincharacteristics of the wearer, such as age, weight or body size, inaddition to the proposed location of the modules on the body, first andsecond wing portion 131, 132 may be made larger or smaller depending onthe fit required for the comfort level associated with continuous wear.Alternative wings 132′ are shown in chain line to illustrate a variationon this embodiment. This embodiment may further comprise an entirelyflexible and adhesive exterior surface.[[.]]

Referring now to FIG. 6, ambient temperature sensor 120 is located alonga portion of upper housing 95 and is directed away from the body of thewearer. Ambient temperature sensor 120 is protected by sensor cover 115.Module 55 contains a central portion comprising printed circuit board140 adapted for insertion within the upper and lower housings 95, 100,which contains circuitry and components generally in accordance with theelectronic configurations described herein. Printed circuit board 140has a power source in the form of a battery 135, which may be eitherpermanently mounted or replaceable. Battery 135 can any one of a coincell, a paper battery, plastic film battery, capacitor, RFID component,solar or other similar device, as would be apparent to those skilled inthe art. Battery 135 and the components of printed circuit board 140 areelectrically connected in a conventional manner to each other andsensors 120, 125 as would be apparent to one skilled in the art (notshown). Printed circuit board 140 further has a first alignment notch155 on one end of printed circuit board 140 centrally located along oneedge of printed circuit board 140. Printed circuit board 140 further hasa second alignment notch 156 on one end of printed circuit board 140centrally located along an opposing edge of printed circuit board 140.

Module 55 further comprises a generally oblong shaped lower housing 100having a recess 141 on its inner surface opposite and corresponding toouter surface protrusion 110 of lower housing 100, as described withrespect to FIG. 3B. Lower housing 100 further comprises a lip 148,extending generally perpendicular from the surface of module and havingan interior wall portion 149 and an exterior wall portion 152. Skintemperature sensor 125 is located along recess 141 of lower housing 100inner surface. Lower housing 100 has alignment pins 145, 146 which aresupported by alignment pin supporting bosses 150, 151.

Upper housing 95 may also benefit from a form that keeps the skin foldsfrom actually touching the ambient sensor in order to maintain thequality of its data, because touching the ambient sensor may compromisethe measurements and accuracy of the output. Alignment pins 145, 146extend in a perpendicular orientation away from lower housing 100 toextend through the alignment notches 155, 156 of printed circuit board140. By extending through the first and second alignment notches 155,156 of printed circuit board 140, printed circuit board 140 is securedto lower housing 100 and is prevented from moving laterally with respectto first and second alignment pins 145, 146. The housing may also besonically welded together with the circuit board being molded, insertmolded, potted or embedded within the housing or other manufacturingtechniques within the ambit of those skilled in the art may be applied.

Referring now to FIG. 7A, a third embodiment of module 55 is presented,also generally in accordance with the geometric housing features of leafspring module 230. Upper housing 95 and lower housing 100 aresymmetrical in this embodiment and are generally constructed aspreviously described with respect to FIGS. 5 and 6. This embodimentfurther comprises a heat flux sensor, generally in accordance with theteachings of Stivoric, et al., U.S. Pat. No. 6,595,929. The heat fluxsensor comprises heat conduit 121 and is operated in conjunction withorifice 123 which extends annularly through the central portion of bothupper and lower housings 95, 100, providing a conduit for ambient airthroughout orifice 123. Heat conduit 121 surrounds the annular orifice123 and extends entirely between the respective surfaces of upper andlower housings 95, 100. Immediately adjacent the annular ends of heatconduit 121 and circumferentially surrounding at least a portion of heatconduit 121 on upper housing 95 is ring-shaped ambient temperaturesensor 120.

Referring now to FIG. 7B, printed circuit board 140 is interposed withinthe space created by housing 95, 100 and may be thermally isolated fromheat conduit 121 by thermal interface 124. Skin temperature sensor 125,analogous to ambient temperature sensor 120 is ring-shaped andcircumferentially surrounds the opening of annular heat conduit 121 atlower housing 100. This embodiment may also incorporate the use ofalternative or additional external sensors or power sources which may bemounted on or integrally with adhesive 300, as would be known to thoseskilled in the art and as illustrated in FIG. 7C, which shows anexemplary placement of additional ambient or skin temperature sensors120. Microphone or other acoustic sensor 168 may optionally be placed oneither the skin or ambient side of the housing to detect motion andsounds such as crying, snoring, heartbeats, eating, drinking and otherenvironmental noises. In the event that electrical communication isnecessary between components located on or in adhesive 300, electricalcontacts 122, 122A are provided on upper housing 95 and adhesive 300,respectively. Adhesive 300 is further provided with orifice 121Acorresponding to orifice 121 of module 55 to permit the passage ofambient air. Adhesive 300 is placed on upper housing 95 and the skin ofthe user consistent with the illustration of FIG. 4.

It is to be specifically noted that a number of other types andcategories of sensors may be utilized alone or in conjunction with thosegiven above, including but not limited to relative and globalpositioning sensors for determination of location of the user; torqueand rotational acceleration for determination of orientation in space;blood chemistry sensors; interstitial fluid chemistry sensors;bio-impedance sensors; and several contextual sensors, such as pollen,humidity, ozone, acoustic, body and ambient noise, including thesesensors, combinations of these sensors, and any additional sensorsadapted to utilize the device in a biofingerprinting scheme, where thewearer can be identified by their physiological signatures, as well ashow their body provides these sensors with certain values and/orpatterns during certain body states and or activities. This is importantwhen a multiplicity of sensors on multiple individuals is contemplatedin a confined space, such as a hospital. It is important to distinguishone wearer from a different wearer, even if just for the sake ofdistinguishing between two people. For example, in a family, where whenone person wears the unit, the unit will automatically understand whothe wearer is, so that there is no need to include demographic or otherinformation before incorporating the data from the product forapplications or correlations where this proper personalization and/oraccuracy is necessary. This same type of biofingerprinting could extendto different locations of the same user's body, so that even if notdistinguishable across different people, the unit could be able todistinguish the location in which is it is being worn. The detection ofthis location will be more apparent with respect to the description ofthe processing of data provided herein.

FIG. 8 illustrates a fourth embodiment of module 55 which is adisposable embodiment comprising patch module 314. It is specificallycontemplated that, as a flexible member, the patch may be of any generalform or shape necessary to adhere comfortably to the body at thenecessary location while providing accurate data. Moreover, the patchembodiments may include certain aspects of the more durable embodimentsdescribed herein or may also include a combination of durable anddisposable components, as will be more fully described herein. Ingeneral, the disposable embodiments conform less to the geometries ofleaf spring module 230 than the durable embodiments. Disposable patchmodule 314 comprises an adhesive patch cover 315 for adhering disposablepatch module 314 to the skin of wearer. Adhesive patch cover 315 has afirst wing portion 316 and a second wing portion 317 and is adapted tohave an aperture in the central portion of adhesive patch cover 315.Disposable patch module 314 further comprises a battery 135, which maybe a paper battery, of the type manufactured by Power Paper, Ltd., beinggenerally oblong in shape. Battery 135 is composed of zinc anode andmanganese dioxide cathode layers printed directly onto paper, plastic orother flexible material which produces electrical energy much likeordinary alkaline batteries. Another alternative is a plastic filmbattery or one of a type manufactured by Cymbet Corporation. Battery 135has two electrodes separated by an electrolyte, and when the electrodesare connected, the circuit is complete and power flows throughdisposable patch module 314. Battery 135 is thin and flexible but is notnecessarily replaceable, but may be rechargeable. Some variants arereplaceable, but not the spirit of the disposable concept. Thisembodiment may also be provided as a self-contained unitary patch whichis completely disposable.

Battery 135 has an upper side 321 that is adjacent to and in contactwith adhesive patch cover 315. Battery 135 further has an aperturelocated in and extending through its central portion that is inalignment with aperture in adhesive patch cover 315 when battery 135 andadhesive patch cover 315 are in contact with each other. Battery 135 ofdisposable patch module 314 further comprises a lower side 322 oppositeupper side 321 that is adjacent to and in contact with a printed circuitboard 325 which supports ambient sensor 120 and skin temperature sensor(not shown). Printed circuit board 325 has a first side 327 facing awayfrom skin on which ambient temperature sensor 120 is located. Thiscircuit board could also be flexible. Ambient temperature sensor 120 islocated in a central location on first side 327 of printed circuit board325 and extends through aperture in both paper battery 320 and adhesivepatch cover 315. Skin temperature sensor is oriented toward the skin ofwearer and is located on a lower side 328 of printed circuit board 325opposite the upper side 327 of printed circuit board 325. Disposablepatch module 314 further comprises a compression material 330 forpressing the sensor against skin as with other embodiments presented,which may also be constructed of multiple densities of material in orderto keep the skin sensor in proper contact, having a upper side 331adjacent to and in contact with lower side 328 of printed circuit board325, generally round in shape and having an aperture in the centralportion that is in alignment with skin temperature sensor (not shown)that is located on lower side 328 of printed circuit board 325 generallycorrelating to orifice 123 as shown in FIGS. 7A-C. Compression materialhas a lower side 332 adjacent to and in contact with a skin interface335. Skin interface 335 is generally round in shape and has an upperside 336 that is adjacent to and in contact with lower side 332 ofcompression material. Skin interface 335 further has a lower side 337that lies adjacent and in contact with the skin when disposable patchmodule 314 is placed on the body of wearer. Skin interface 335 furtherhas an aperture in its central portion through which skin temperaturesensor (not shown) extends through and is in contact with the skin ofwearer.

Additional considerations relating to the use of batteries include avariety of alternatives. The same battery may be removed from a deviceand reused, especially if the battery is a durable coin or button celland the unit is disposable. The module may be specifically designed toaccept the insertion of the battery, or even retain the battery throughan undercut or an opening along the edge, the use of the adhesive orpressure from the skin itself.

One significant consideration with respect to disposable embodiments istime of wear and condition. A deteriorated device may provide inaccuratedata without other indication of failure. Certain sensors, such as apiezoelectric strain detector may be utilized, as well as a mereelectrochemical visual indicator to alert the user that a present timeor performance limit has been reached and that the unit should bereplaced. Other example displays include thermal-chemical, chemical),light-chemical and bio-chemical. The displays or detectors can beintegrated into a portion or the entirety of the adhesive, in which theadhesive can be printed with different imagery. As the body moves, thecollective movements could result in disruption of the material orcracking of the surface of the adhesive so that what is presented isalso a mechanical, non-electronic sensor that exposes the activity ofthe wearer in addition to the temperature readings. This is applicablefor determining the end of life of the product, as a basic activity ormotion detector as well as a tampering detector, as described above.

A second consideration is power utilization. Although battery basedembodiments are described and generally preferred, it is specificallycontemplated that the unit may be powered by an external source, such asRF transmissions which contain sufficient power to enable the device tooperate for a short period of time sufficient to take readings andtransmit data. These embodiments are today not yet appropriate forcontinuous and/or long term measurement applications.

As with any inexpensive, disposable product, reduction of components andcomplexity is necessary for utility. This may include the use ofconductive inks on the battery or integrated into the adhesive forelectrical contacts. Additionally, elimination of switches and othercontrols are desired. An additional reason for elimination of on/offswitches in favor of automatic startup is if the parent or caregiverforgets to turn on the device. On a durable or semi-durable module, theskin temperature sensor may be utilized as a power up detector, so thatwhen the unit is affixed to the body, it turns on, eliminating an off/onswitch and also improving power savings when the unit is not in use. Themodule may be configured to go to sleep for periods of time or takereadings more occasionally to save the battery. The length of theseperiods may be set by the user, the caregiver or may be dynamically set,based upon the readings observed. For example, an elevated temperaturemay cause the device to take readings more frequently. Othermethodologies of automatically sensing a condition to initiate operationof the device include sensing certain conditions as well as detectingcertain environmental changes. For example, galvanic skin responsesensors and/or heat flux sensors could be utilized to detect when thedevice is placed on the body. When the device is at ambient temperatureand not on the body, the ambient and skin temperature sensors willreport the same temperature. Once the device has been placed on thebody, the temperature readings will diverge, which can be detected bythe unit and utilized as a signal to begin operation. A motion detectormay also signal mounting on the body. Other methodologies include theuse of proximity detection or contact between the device and thereceiver, for example, or the placement of the adhesive on the device.Inserting the battery may also initiate operation. Lastly, a signalcould be generated from the receiver to wake up the device.

In conjunction with durable embodiments, disposable embodiments orcombinations thereof, and as previously discussed, multiple units couldbe disposed on the body to create an array of sensors. Additionally, thearray could be disposed on a single unit, using outboard sensorspositioned on the adhesive or a wing. Lastly, the sensors could becompletely physically separate, yet communicate with the single unit.

As previously discussed, certain embodiments may also be utilized forthe delivery of medication, nutriceuticals, vitamins, herbs, minerals orother similar materials. The adhesive or the module itself may beadapted to topically apply medications in a manner similar to atransdermal patch. This functionality may also be implemented throughthe use of coated microneedles. Alternative on-demand delivery systemssuch as the E-Trans transdermal drug delivery system manufactured byAlza Corporation may also be included, with the capability of applyingthe medication at a specific time or when certain preset criteria aremet as determined by the detection and processing of the device. Forexample, the temperature module could be coupled with an adhesive thatdelivers pain reliever to help with fever reduction. The drug deliverycould be controlled or dosed or timed according to thereactions/measurements and derivations from the body. The set point forthis closed loop may be factory set, or set on the device by the user orcaregiver. The system may not employ a closed loop but the caregiver,through the receiver, may issue commands for some skin delivery tooccur. Other examples include administering limited duration medicationssuch as a four hour cough medicine while sleeping at the appropriatetime. As stated more fully herein, the device is further capable ofdetermining certain aspects of sleep recognition. In such embodiments,sleeping aids may be administered to help people sleep or, as they getrestless in the middle of the night, be provided with an appropriatedosage of a sleep aid. Moreover, the ability to detect pain prior tofull waking may allow the administration of a pain reliever. In thesecases, remedial measures may be taken prior to waking, upon thedetection of physiological and/or contextual signals recognized by thesystem as precursors of a waking event. This permits the user to enjoy amore restful and undisturbed sleep period. Additionally, the personcould be awoken after 8 hours of actual biological sleep rather than byarbitrary time deadlines. The device may also be utilized for theprevention and/or treatment of snoring or sleep apnea throughbiofeedback.

An alternative embodiment utilizes the capabilities of the system torecognize and categorize certain pre-urination or bowel movementconditions, parameters and/or contexts. This may be useful in addressingbed wetting and bathroom training in both children and adults. Forexample, if the device is worn for some period of time during whichthese events occur, the system builds a knowledge base regarding themeasured and derived parameters immediately prior to the events. Theseparameters may then serve as signals for an impending event and maytrigger an alarm or other warning. This will allow a parent or caregiverthe opportunity to reinforce proper bathroom habits or to awaken asleeping child or unaware adult to go to the bathroom.

The adhesive could be a bioactive dressing that when placed on a burnarea or suture, for example, while monitoring blood flow essential fortissue regeneration, may also enabled with stimulatingmaterials/minerals/substances to aid in the healing process. Thisprovides a protective cover for the wound, encouraging healing, with adevice capable of evaluating whether the process is actually occurringand successful. The device may also provide very modestelectro-stimulation for tissue or muscle regeneration.

The adhesive may also be designed to react to chemicals presence innormal moisture and/or perspiration from the skin, exposing results toobservers through chemical reactions that result in color or othervisual feedback as to the parameters sensed. These may include: sodium,chloride, potassium and body minerals. Potential conditions could berecognized such as: cystic fibrosis or substance use. The adhesive,which may be exposed to the diaper or adhered to inside of diaper orextended to a region of the body where urine will be contacted upon aninsult, may be provided with certain chemical detectors for: pH,specific gravity, protein, glucose, ketones, nitrite, leukocyte,urobilinogen, blood, bilirubin, ascorbic acid, vitamin C and other likeminerals and compounds. If the adhesive is further provided withmicroneedles, probing into interstitial fluid through various chemical,electrical or electrochemical technologies may collect and/or presentdata regarding: proteins, various nutrients, glucose, histamines, bodyminerals, pH, sodium, pO2, pCO2, body fluid status including hydration,with additional condition feedback about glucose and substance use.These adhesives could also include electrodes, potentially integratedwith specific gels to allow technologies for non-invasive detection oftrends and tracking of glucose levels utilizing weak electronic currentto draw tiny volumes of tissue fluid through the skin for analysis ofthe fluid for glucose levels. Electrodes may be provided for ECG,galvanic skin response, EMG, bio-impedance and EOG, for example.

A fifth embodiment of module 55 of the present invention is a disctemperature module 534 as illustrated in FIG. 9. Disc temperature module534 comprises a disc 535 having a round base 536 and a roundprotuberance 537 extending from round base 536. Round protuberance 537has a diameter smaller than the diameter of round base 536. The roundprotuberance 537 of disc 535 has a face 538 which further comprisesdisplay 86A. Optional display 86A visually presents continuous detectedtemperature measurements and other relevant, statistical data includingprocessed data such as current temperature, temperature trends, andcontextual data can be shown. Ambient sensor 120 is located on face 538and skin temperature sensor (not shown) is located on the underside ofdisc 535 and is adjacent to and in contact with the skin of wearer.Ambient temperature sensor 120 may cover substantially all of face 538of disc 535. Adhesive material may be placed on the under or skin sideof module 534. Additionally an adhesive and/or insulating ring may beutilized in order to maintain the module on the body as will bedescribed further herein.

Disc temperature module 534 may further comprise a detachable handle 570having a handle projection 571 extended from one end of detachablehandle 570. Detachable handle 570 may be connected to round base 536 ofdisc 535 by inserting handle projection 571 into an opening located onround base 536 to take a preliminary temperature measurement. In thisembodiment, handle 570 is affixed to module 534 and the module is merelyplaced, not adhered to the designated location, such as under the arm ofthe patient. A static or preliminary reading is made and the handle isdetached. The module 534 may then be affixed to the body or utilized ina static manner at a later time. Handle 570 may also comprise a skintemperature sensor 125A and/or an ambient temperature sensor 120A. Thehandle skin temperature sensor 125A may be utilized in conjunction withthe module as a traditional oral or axillary thermometer to take staticreadings. Additionally, periodic confirmations of the operation of thedevice may be made by reattaching the module to the handle after someperiod of on-body use and taking an oral, rectal or other temperature toallow the device to check its calibration, as will be described morefully herein. In the instance where the module is removed for such acalibration, a new warm up period may be required. An alternative toeliminate such additional warm up periods is to provide a similarhandle, reader or thermometer in electronic communication with themodule that has a thermometer integrated therein for temperaturemeasurement which will update the module without removal.[[.]]

An alternative embodiment may include the integration of handle 570 andface 538 with display 86A, with a detachable sensor unit comprising disc535 and the adhesive material. In this embodiment, the integrated handle57 and face 538 comprise a receiver unit, as more fully describedherein, with the detachable disc comprising the module to be affixed tothe skin. In this embodiment, ambient temperature sensor 120A may alsobe utilized to detect the ambient temperature of the room, if thehandle/receiver is within the same environment. These embodiments, intheir most rudimentary forms, may merely measure relative temperaturechange rather than actual temperature. In this embodiment, a baselinetemperature reading would be made with another device. In mostembodiments of this type, the module would be preset to alarm or triggera warning or other event upon meeting a preset criteria. An example ofthe utility of such a device is within a hazmat suit or firefighter'sfire resistant clothing to detect when heat and lack of ventilation maycause body temperatures to rise to dangerous levels.

Disc temperature module 534 further comprises a round adhesive backing545 having a flat surface 572 that adjoins a raised area 573 having around shape with a diameter less than total diameter of the roundadhesive backing 545. Raised area 573 has an opening 560 in a centralportion that is defined by the perimeter of raised area 573. Flatsurface 572 further comprises a pull tab 565 extending from flat surface572.

Disc 535 can be engaged with adhesive backing 545 by inserting disc 535into recess 560 of adhesive backing 545 so that the raised area 573 ofadhesive backing 545 is in contact with round protuberance 537 of disc535 forming an adhesive disc assembly 550. The adhesive disc assembly550 is placed at an appropriate location on the body of wearer. When thewearer chooses to remove the disc temperature module 534 from the body,pull tab 565 is lifted to aid in the removal of the adhesive discassembly 550 from the body of wearer.

FIG. 10 represents a sixth embodiment of module 55 in the form of aself-contained module 445. Self-contained module 445 is constructed of adurable material, preferably flexible urethane or an elastomericmaterial such as rubber or a rubber-silicone blend by a molding process.Alternatively, self-contained module 445 may also be constructed from arigid plastic material.[[.]] Self-contained module 445 has a display fortransmitting information including, but not limited to, electrochemicaldisplay 450. Electrochemical display 450 contains an electrochromic dyethat changes color when a voltage is applied across the dye. After thevoltage is removed from the dye, the resulting color remains.Self-contained module 445 can be programmed such that when apredetermined threshold is reached, the electrochemical display 450changes to reveal an image. The electrochemical display 450 may furtherhave a removable adhesive-backed object on top of the electrochemicaldisplay 450 containing electrochemical dye such that the adhesivechanges color or image when the threshold is reached. Theadhesive-backed object is then removed from the electrochemical display450 for placement elsewhere other than on the body or on self-containedmodule 445. This electrochemical display may furthermore be adapted forspecific user types, feedback thresholds or user goals and provided foreach particular application, such as 6 month old infants, firefighter orsurgical suit.

FIGS. 11A through 11G illustrate a seventh embodiment of the presentinvention in the form of a folded clip module 495. FIG. 11A illustratesa folded clip module 495 having a first portion 510 and a second portion515. FIGS. 11B and 11C illustrate one embodiment of folded clip module495. In FIG. 11B, folded clip module 495 has a first portion 510 whichis constructed from a durable material, preferably of flexible urethaneor an elastomeric material such as rubber or a rubber-silicone blend bya molding process. Alternatively, first portion may be a rigid plastic.First portion 510 further has a circular face 520 on which display 86Ais located. Display 86A visually presents continuous detectedtemperature measurements and other relevant, statistical data includingprocessed data such as current temperature, temperature trends, andcontextual data can be shown.

First portion 510 of folded clip module 495 has a narrow extension piece521 that connects face 520 of first portion 510 to second portion 515 offolded clip module 495. The second portion 515 of folded clip module 495is constructed from a malleable material, preferably of flexible circuitboard or urethane or an elastomeric material such as rubber or arubber-silicone blend by a molding process. As illustrated in FIG. 11C,folded clip module 495 is bent at the location at which extension piece521 adjoins second portion 515 of folded clip module 495 for attachmentto diaper 60 of wearer.

The another embodiment of folded clip module 495 is illustrated in FIGS.11D and 11E. In FIG. 11D, folded clip module 495 has a first portion 510which is constructed from a durable material, preferably of flexibleurethane or an elastomeric material such as rubber or a rubber-siliconeblend by a molding process. Alternatively, first portion may be a rigidplastic. First portion 510 further has a circular face 520 on whichdisplay 86A is located. Display 86A visually presents continuousdetected temperature measurements and other relevant, statistical dataincluding processed data such as current temperature, temperaturetrends, and contextual data can be shown.

First portion 510 of folded clip module 495 has a narrow extension piece521 that connects face 520 of first portion 510 to a hinge 525. Hinge525 is used to connect first portion 510 of folded clip module 495 tosecond portion 515 of folded clip module. The second portion 515 offolded clip module 495 is constructed from a malleable material,preferably of flexible urethane or an elastomeric material such asrubber or a rubber-silicone blend by a molding process. As illustratedin FIG. 11E, folded clip module 495 is bent at the location hinge 525for attachment to diaper of wearer. This embodiment may also be utilizedin conjunction with adhesives for further ensuring good contact with thebody, or for affixation to the garment or diaper. With respect to theskin mounted adhesives, the adhesive materials and mounting areconsistent with the descriptions provided with respect to FIGS. 4-8.

In both embodiments of folded clip module 495, ambient temperaturesensor (not shown) is located along the first portion 510 of folded clipmodule 495 and skin temperature sensor (not shown) is located along thesecond portion 515 of folded clip module. The ambient and skintemperature sensors, however, may be located solely on the secondportion, which may, in turn, be disposable, with or without the flexiblesection.

FIGS. 11F and 11G illustrate the mounting locations of folded clipmodule 495 on diaper 60 of wearer. In FIG. 11F, folded clip module canbe mounted to diaper 60 at first mounting location 505 located on theleg band of diaper 60. The first portion 510 of folded clip module 495is placed exterior to diaper 60 and the second portion 515 of foldedclip module 495 is placed under diaper 60. FIG. 11G illustrates foldedclip module 495 mounted to diaper 60 at a second mounting location 505located on the waist band of diaper. As described in FIG. 11F, the firstportion 510 of folded clip module 495 is placed exterior to diaper 60and the second portion 515 of folded clip module 495 is placed underdiaper 60. This mounting technique may also be utilized in conjunctionwith other garments and for adult use. Furthermore, the housingsutilized in conjunction with this embodiment may be detachable from thefolding sections in a manner consistent with both the embodiments ofFIGS. 7-9 in that certain functions and/or power sources may be locatedin disposable sections, with a durable housing which is reused. Thepower may, alternatively, be located in the diaper or garment upon whichthe module is mounted or supported.[[.]]

FIG. 12 represents an eighth embodiment of a temperature monitor modulewhich is a stack monitor module 575. Stack monitor module 575 comprisesa first portion 580, which is a flat disc having a circular shape havinga first side 581 and a second side (not shown). The first side 581 offirst portion 580 has an ambient temperature sensor 120 which facestoward the environment of the wearer. First side 581 of first portion580 also has a display 86A. Display 86A visually presents continuousdetected temperature measurements and other relevant, statistical dataincluding processed data such as current temperature, temperaturetrends, and contextual data can be shown. Electrical connections areconsistent with those described with reference to FIGS. 7 and 8. Thesecond portion 585 of stack monitor module 575 has a first side 586 anda second side 587. The first side 586 of second portion 585 is placed incontact with diaper 60. Skin temperature sensor 125 is located on secondside 587 of second portion 585 of stack monitor module 575 and is placedadjacent to and in contact with the skin to detect skin temperature ofthe wearer. The second side 587 of second portion 585 may also have asingle sensor or a multi-sensor array of skin temperature sensors 125.Second side (not shown) of first portion 580 and first side 586 ofsecond portion 585 are placed in contact with diaper 60 and engagedthrough a piercing connection. The diaper or garment may already have anappropriately labeled and located hole, pocket, undercut or the like forreceiving and/or locating the device.

FIG. 13 illustrates a ninth embodiment of the present invention in theform of a clip module 475. Clip module 475 is constructed of amalleable, flexible material such that clip module 475 can maintain itsshape while attached to diaper 60. Clip module 475 is preferablyflexible urethane or an elastomeric material such as rubber or arubber-silicone blend by a molding process. Clip module 475 has aninterior clip portion 480 on which skin temperature sensor 490 islocated. Clip module 475 further has an exterior clip portion 485 onwhich ambient temperature sensor is located. Ambient temperature sensor(not shown) can be large enough such that the entire surface of exteriorclip portion 485 can be the active sensor area, or the active sensor canbe located only on a portion of exterior clip portion 485. Similarly,skin temperature sensor 490 can be large enough such that the entiresurface of interior clip portion 480 can be the active sensor area, orthe active sensor can be located only on a portion of interior clipportion 480. The interior clip portion 480 of clip module 475 is placedunder the waistband of diaper 60. Clip module 475 is bent such thatexterior clip portion 485 that rests on top of diaper 60.

FIG. 14 illustrates a tenth embodiment of module 55, which is aposterior mounted module 455, and its placements on the wearer.Posterior module 455 is constructed of a malleable, soft body-formingmaterial, preferably a soft non-woven multilayered material, but mayalso be a flexible urethane or an elastomeric material such as rubber ora rubber-silicone blend by a molding process. Alternatively, posteriormodule 455 may also be constructed from a rigid plastic material whichis otherwise padded or adhered to the body consistent with theembodiments described above. Consistent with the other modules,posterior module 455 has a housing (not shown), which further comprisesa left wing portion 460 and a right wing portion 455. A central portion470 of posterior module 455 is located between the left and right wingportions. Posterior module 455 may slip into a pouch built into diaperor be positioned in between diaper 60 and small of back of wearer.Additionally the module may be adhesively mounted, as describedpreviously, in the upper portion of the back between the shoulder bladesas illustrated in FIG. 14 by chain line.

Finally, FIG. 15 illustrates an eleventh embodiment of the receiver inthe form of a ring 370. Ring 370 may be a receiver but may also be aself contained single module unit as previously described. Base 371 isconstructed from a flexible urethane or an elastomeric material such asrubber or a rubber-silicone blend by a molding process, although base371 may also be constructed from a rigid plastic material. Base 371contains all of the necessary components for receiving data from aseparate module 55, or may contain all of the components of module 55itself and take temperature readings from the finger itself. Thetemperature and other relevant data received from module 55 is displayedon display 86B of base 371. Base 371 is sized to fit on an appropriatefinger of an individual. Receiver ring 370 provides portability andmobility to the user so that the user can move to a distance within thearea as defined by the transmission method used by module 55 to transmitdata to receiver ring 370. In the embodiment shown in FIG. 15, an analogdisplay is provided with respect to display 86B. It is to bespecifically noted that any display of any embodiment may be digital oranalog, electronic, or electro-mechanical. Displays may beinstantaneous, as will be described more fully herein, or may becumulative, in the sense that temperature trends may be displayed. Withrespect to display 86B in FIG. 15, the display could be a typicalthermometer gauge which displays the current temperature on a relativescale. This device may be particularly useful as an ovulation detectoror contraceptive indicator for women, and may enabled to indicate peaktemperatures over a time period to assist in determining ovulation, forexample, 30 days, with a power source matched for such length ofintended use. Additionally, it may be utilized, similar to the bathroomtraining embodiment above, for detecting pre-menstrual signals andprovide a warning regarding the impending event. This may be useful fora number of applications, including familiarizing and/or educating youngwomen with little menstrual experience about anticipating and addressingtheir needs. This application has equal utility for use with menopausalwomen, in that these temperature readings may be utilized in detecting,characterizing, trending and predicting hot flashes and managing thischange in life.

It is important to note that the embodiments described above are, inconjunction with the circuitry and programming described below, adaptedfor use with all types of patients and wearers. For example for adultswho do not wear diapers, the clip modules could be clipped onto aperson's underwear. The devices are generally intended to bepreprogrammed with appropriate information, algorithms and flexibilityto adapt to any wearer and to calibrate itself to that particular use.Other embodiments, most notably the disposable embodiments describedabove, may also be further reduced in complexity and cost by limitingthe functionality of the device. This may be done in an effort toproduce the lowest cost embodiment or to increase the specificity of theapplication for which the device is intended. In either case,functionality may be limited by reducing the processing capabilities ofthe device, as will be described in more detail herein and/or byreducing the available range of functions. The functional range of eachdevice may be limited, for example, to a certain weight range for thepatients, so that infants, children and adults will each receive adifferent type of monitoring device. Moreover, as weight has a primaryeffect on the data derivation, as will be described more fully herein,finer gradations of weight applicability may be developed andpreprogrammed into a series of specific weight range products.Additionally, other responsive parameters may be determined to permitdifferentiation between embodiments, with a training device worn forsome initial period to allow the system to categorize the user accordingto a particular parameter or characteristic, the output of which is adetermination of which of a series of alternative devices is appropriatefor the user. By having several modules for different sizes of users or,alternatively, the adhesive or garment type, the module may be providedwith a built in estimate of the size of the user which it mayincorporate into its calculations without having to have that size inputexplicitly.

A typical receiver 345 and example of a display is illustrated in FIG.10. The display may be incorporated into any one of the receivers asdiscussed with respect to FIG. 1. A current temperature 350 is shown onthe display and is the latest calculated temperature of the individualas determined from the detected measurements of module 55. Thecalculation of the temperature is further described herein with respectto FIG. 22. The display of receiver 345 is further adapted to includeother information such as current day of week 355, current month 360,current date 361 and current time 365. The operational status ofreceiver 345 is controlled by power button 366. Delivery of battery orelectrical power to the receiver 345 is regulated by the depression orother manipulation of power button 366. Upon power delivery, thereceiver 345 will begin to receive signals from module 55. Receiver 345displays feedback from the modules, which may be as simple as an iconicor color based indicator relating to daily activity level or bodyfatigue, such as is when working in a surgical, fire retardant,biological or hazardous material suit where the body is unable tobreathe as was previously described. The results may also convey andindication that a threshold was met. In addition the display may bedivided by chronology, calendar and the like.

As temperature changes, the display can also present an iconic, analogor digital indication as to the trend of change, such as moving thedigits up or down similar to an odometer to indicate rising or fallingtemperatures, respectively. Graphical or iconic output may incorporatesleeping, crying and/or orientation for example. As shown in FIG. 17, aniconic presentation is illustrated, having current temperature 350 bethe latest calculated temperature of the individual as determined fromthe detected measurements of module 55. Current temperature 350 can bedisplayed in Celsius or in Fahrenheit mode and the mode selected fordisplay is indicated by temperature scale indicator 380 and displays a Cfor Celsius or an F for Fahrenheit. The display includes an orientationindicator icon 430. Orientation indicator icon 430 provides an iconicrepresentation of the orientation of wearer. The orientation indicatoricon 430 can be a sound or an illustration or icon of an individual in acertain body position or orientation indicator icon 430 can be aalphabetical symbol such as L for left, R for right, S for stomach and Bfor back. The display further provides an activity indicator text 435.The activity indicator text 435 provides information on the activitylevel of the wearer to indicate if the wearer is sleeping, awake orcrying. Heart rate indicator 440 provides a measurement of the heartrate of the wearer. Heart rate indicator may be replaced by an indicatorthat displays one of another type of vital sign status.

FIG. 18A illustrates a display of receiver 345. The current temperature350 is the latest calculated temperature of the individual as determinedfrom the detected measurements of module 55. The calculation of thetemperature is further described herein with respect to FIG. 23. Currenttemperature 350 can be displayed in Celsius or in Fahrenheit mode andthe mode selected for display on receiver 345 is indicated bytemperature scale indicator 380 and displays a C for Celsius or an F forFahrenheit. Battery indicator 385 indicates the power level of thebattery of module 55 or the selected alternative embodiment. Abnormaltemperature alert indicator icon 390 flashes a visible alert when aborderline low or high temperature is detected. The high temperaturealert indicator 390 may be accompanied by abnormal temperature alerttext 395 which is high temperature alert indicator 390 in a textualformat. Display 86B may also be rendered as a tactile device, a motor,electronic stimulation or other technologies for use by the visuallyimpaired, including, but not limited to an array of reading pins tocreate a moving Braille-like display, as developed by NASA's JetPropulsion Laboratory.

FIG. 18B represents a second embodiment of a display of receiver 345.The display includes current temperature 350, temperature scaleindicator 380 and battery indicator 385, as described with respect toFIG. 18A. In addition, the display includes quick shift alert indicatoricon 400 that visibly alerts the user when the temperature changes by apreprogrammed number of degrees in either a rising or fallingtemperature state or any other rapid change in condition or context. Thequick shift alert 400 may be accompanied by quick shift alert text 405that illustrates the quick shift alert 400 in a textual format.

A third embodiment of the display of receiver 345 is shown in FIG. 18C.The display includes current temperature 350, current temperatureindicator 380, battery indicator 385, as described with respect to FIG.18A. The display also includes temperature trend information including aprevious temperature 420 which indicates a previous temperature asdetected by module 55, the calculation of which is further describedwith respect to FIG. 22. Previous temperature 420 has an associatedprevious temperature time text 425 which indicates the time at which thedetected previous temperature 420 was current. The display illustratedin FIG. 18C further includes a temperature trend indicator icon 410,which is an iconic representation of the pattern of temperature over acertain period of time, and temperature trend indicator text 415 whichis the textual representation of temperature trend indicator icon 410.It is to be specifically noted that the receiver and related displaysmay be incorporated into any other device commonly found in the home,office, health care institution or the like, including but not limitedto a weight scale, television, phone base station or hand set, exerciseequipment, blood pressure monitor, glucometer or clock radio.

FIG. 19 shows an electrical block diagram of the circuitry of a module55. Module 55 includes a first sensor 610 and a second sensor 615. Firstsensor 610 is a skin temperature sensor that detects the skintemperature of the body at the skin area of placement on the wearer andgenerates a signal to be sent to a processor 605. Second sensor 615 isan ambient temperature sensor which detects the ambient air temperatureof the environment of the wearer and also generates a signal to be sentto processor 605. Depending upon the nature of the signal generated bysecond sensor 615, the signal can be sent through amplifier 635 foramplification. Once the signals generated by second sensors 615 are sentto processor 605, the signals may be converted to a digital signal by ananalog-to-digital converter contained with the processor 605.

A digital signal or signals representing detected temperature dataand/or other relevant information of the individual user is thenutilized by processor 605 to calculate or generate current temperaturedata and temperature data trends. Processor 605 is programmed and/orotherwise adapted to include the utilities and algorithms necessary tocreate calculated temperature and other related data.

It should be understood that processor 605 may also comprise other formsof processors or processing devices, such as a microcontroller, or anyother device that can be programmed to perform the functionalitydescribed herein. It is to be specifically noted that the circuitry maybe implemented in a minimal cost and component embodiment which may bemost applicable to a disposable application of the device. In thisembodiment, the apparatus is not provided with a processor, but asseries of discrete electrical components and gate circuits for highlyspecialized preprogrammed operation in accordance with any of theembodiments described herein. This apparatus may be powered by any knownmeans, including motion, battery, capacitor, solar power. RFID or othermethods known to those skilled in the art. Another option is to powerthe apparatus directly from the voltage potentials being measured. Thedisplay mechanism may be chemical, LCD or other low power consumptiondeice. The voltage spikes charge up a capacitor with a very slow tricklerelease; a simple LED display shows off the charge in the capacitor. Inanother embodiment, a simple analog display is powered by the battery.

The detected or processed data and/or other relevant information of theindividual user can be sent to memory, which can be flash memory,contained within processor 605. Memory may be part of the processor 605as illustrated by FIG. 20 or it may be a discrete element such as memory656 as shown in FIG. 20. To the extent that a clock circuit is notincluded in processor 605, a crystal timing circuit 657 is provided, asillustrated in FIG. 20. It is specifically contemplated that processor605 comprises and A/D converter circuit. To the extent such is notprovided, an A/D circuit (not shown) may be required. Sensor inputchannels may also be multiplexed as necessary.

Battery 620 is the main power source for module 55 and is coupled toprocessor 620. A transceiver 625 is coupled to processor 620 and isadapted to transmit signals to a receiver in connection with module 55.Transceiver communicates detected and/or processed data to receiver byany form of wireless transmission as is known to those skilled in theart, such as infrared or an RF transmission. Antenna 630 is furthercoupled to processor 605 for transmitting detected and/or processed datato the receiver. Antenna 630 may further be mounted or incorporated intoa diaper, garment, strap or the like to improve signal quality.

FIG. 20 illustrates an electrical block diagram of a stand alone versionof module 55. The stand alone version of module 55 provides a means foruser input 655. User input 655 may include initial temperaturemeasurement as manually measured by user or characteristics of thewearer such as age, weight, gender or location of the module. Module 55includes a first sensor 610 and a second sensor 615. First sensor 610 isa skin temperature sensor that detects the skin temperature of the bodyat the skin area of placement on the wearer and generates a signal to besent to processor 605. Second sensor 615 is an ambient temperaturesensor which detects the ambient air temperature of the environment ofthe wearer and also generates a signal to be sent to processor 605.Temperature sensors are generally implemented as thermistors, althoughany temperature sensing devices are appropriate. These sensors generallycomprise 1% surface mount thermistors applied using standard automatedSMT placement and soldering equipment. A 1% R25 error and 3% Beta errorfor each sensor means that each sensor is +/−0.5 degrees C. around the35 degree C. area of interest. In certain circumstances, this may resultin a 1 degree C. error in temperature reading between the two sensors.To reduce error, the sensor is submerged into a thermally conductive butelectrically insulative fluid, such as 3M Engineered Fluids Fluorinertand Novec, and allowed to stabilize. By reading the two thermistorsunder this known condition of identical temperatures at two temperaturesetpoints, the relationship between the R25 and Beta of the twothermistors may be determined.

It is also possible to incorporate more costly thermistors with 0.1degree C. interchangeability. This reduces the inter-sensor error by afactor of 10 to 0.1 degree C. It is also possible to match sensorsduring the manufacturing process utilizing a batching process as wouldbe known to those skilled in the art.

A digital signal or signals representing detected temperature dataand/or other relevant information of the individual user is thenutilized by processor 605 to calculate or generate current temperaturedata and temperature data trends. Processor 605 is programmed and/orotherwise adapted to include the utilities and algorithms necessary tocreate calculated temperature and other related data. Processor 605 mayalso comprise other forms of processors or processing devices, such as amicrocontroller, or any other device that can be programmed to performthe functionality described herein

Battery 620 is the main power source or module 55 and is coupled toprocessor 620. Module 55 is provided with output 86A that presents multicomponent system includes module 55 that may be provided with display86A for visual display of current temperature, temperature trends, andcontextual data. Alerts can be reported in many non-visual forms aswell, such as audio, tactile, haptic and olfactory, for example. Alertsmay also be made through a computer network or by wireless transmission.

FIGS. 21A and 21B illustrate an electrical block diagram of a multicomponent system incorporating module 55. FIG. 22A contains all of thecomponents as described in FIG. 21 with respect to the stand-aloneversion of module 55. In addition, module 55 further comprises atransceiver 625 is coupled to processor 620 which is adapted to transmitsignals to a receiver in connection with module 55. Transceivercommunicates detected and/or processed data to receiver by a short rangewireless transmission, such as infrared or an RF transmission. Antenna630 is further coupled to processor 605 for transmitting detected and/orprocessed data to the receiver.

FIG. 21B illustrates the circuitry of a receiver used in connection withmodule 55. User input 680 may include initial temperature measurement asmanually measured by user or characteristics of the wearer such as ageor weight. Processor 675 receives processed data from module 55 ascurrent temperature data, and temperature data trends and contextualdata. Process 675 may be programmed and/or otherwise adapted to includethe utilities and algorithms necessary to create calculated temperatureand other related data. Digital signal or signals representing detectedtemperature data and/or other relevant information of the individualuser may be received and utilized by processor 675 to calculate orgenerate current temperature data, temperature data trends andcontextual data. Processor 675 may also comprise other forms ofprocessors or processing devices, such as a microcontroller, or anyother device that can be programmed to perform the functionalitydescribed herein. An RF receiver 670 is coupled to processor 675 and isadapted to receive signals from transceiver of module 55. RF receiver670 receives processed data by a short range wireless transmission, aspreviously described. Antenna 665 is further coupled to processor 605for transmitting detected and/or processed data to the receiver. Theantenna, in order to be longer and have been transmission qualitiescould be integrated into the adhesive. Transmission means may include,for example, RF, IR, sound and protocols such as Ethernet, Bluetooth,802.11, Zigbee and GPRS.

It is to be specifically noted that any of the programmable features ofthe devices may be rendered as series of discrete circuits, logic gatesor analog components in order to reduce cost, weight or complexity ofthe device which may be developed by the algorithmic method described inAndre, et al., copending U.S. patent application Ser. No. 09/682,293.This is especially true with respect to the disposable embodiments andmore particularly, the graded or categorized devices described above.

Battery 620 is the main power source for receiver and is coupled toprocessor 670. The battery 620 may be recharged by induction or wirelesscommunication.[[.]] Another alternative is the use of RFID systems,where the internal power reserve of the unit is merely enough to storedata until more fully powered by being showered by RF signals.

The device may be further enabled, in conjunction with RFID systems, tosend a data bit to a reader or when a wand is waved over or brought inproximity to the wearer. With the wireless capability, there is also thecapability to have other passive RFID tags, such as stickers, placedaround the house at locations that are unsafe, such as a stairway. Inthis embodiment, a warning could be sounded or sent to a receiver if thewearer approaches the RFID tag denoting a dangerous location. This maybe implemented in a fully powered embodiment or in a product that isexternally powered.

An alternative power system, such as that developed by Firefly PowerTechnologies, Pittsburgh, Pa. is another subtle variant with regards topowering products. In that system, by either collecting the ambientmagnetic field or RF bandwidth or alternatively showering an area with aknown and consistent RF bandwidth powers a module having only acapacitor and no battery, which is trickle charged until a certain powercapacity is collected or a certain amount of time has passed. The unitis then powered up, the necessary readings taken/recorded and thenpassed on wirelessly with acknowledgement that the data reached thedestination or held in flash memory until the next time the power up andwireless connection is initiated and established. The unit would thenpower down and begin its next cycle or recharge. Aura Communications'LibertyLink chip is another alternative that creates a weak magneticfield bubble and transmits by modulating the magnetic field at lowfrequencies of approximately 10 MHz.

FIG. 22 illustrates the gross operation of a temperature measurementmodule. Skin temperature sensor initially detects skin temperature 700and ambient temperature sensor initially detects a diaper temperature705 corresponding to the ambient environment of the individual. Themodule is subject to calibration 800 to aid in the accuracy of thedetection of skin temperature by skin temperature sensor. One method ofcalibration includes the temperature measurement of the wearer with adigital temperature measurement device which is automaticallytransferred to the module. Once the initial temperature of the wearer isreceived by the module, the unit is set to the wearer's initial startingtemperature and uses this temperature as a basis for the relativechanges that occur while the temperature module is in contact with thewearer.

If an initial temperature of the wearer is not received through abaseline calibration, the module will calibrate itself over a period oftime after being on the body, as well as adapt and/or modify thecalculations and/or algorithms over time as part of a learning process,as described more fully in Andre, et al., copending U.S. patentapplication Ser. No. 10/682,293 and others identified above. During thistime of initial wear, while the module is being calibrated, anyparticular unexpected changes in temperature are stored for latercharacterization. The module creates a history of measurements that arecategorized for further contextual analysis as similar unexpected valuesare detected.

In detail, calibration 800 can take one of two embodiments: sensorcalibration and personalization of the system to the particular wearer.In sensor calibration, the individual sensors are calibrated against oneanother based on laboratory adjustments or first readings from thedevice before each is applied to the skin. The appropriate offset and,optionally, a slope or linear (or non-linear) function are chosen foreach sensor. In personalization, a secondary reading of core temperatureis taken and utilized for the purposes of calibrating the device to theindividual. For example, a parent may take their child's temperaturethrough another means before placing the module on the child. This valuecan be utilized to personalize the algorithm for that child bycorrelating the detected measurements of the module with the actualtemperature recorded by other means.

Alternatively, detectable events may occur which permit furthercalibration of the system. As one example, if the module is placed inthe diaper in such a way as to have a portion of the sensor, if not themodule itself, placed in a way to sense the temperature of urine whenfreshly present in the diaper, the temperature of this urine, asdetected by the ambient sensor, can be utilized to aid in calibratingthe module.

However, any readings being made in the diaper, whether for infant,toddler, or adult benefits from the recognition of these events and beable to filter out this noise during, but especially after, theintroduction of the urine to the diaper because of the chemical reactionof the diaper which increases temperature momentarily. Additionalinformation can improve the accuracy of the system over time.

Finally, another form of calibration is to input into the system thewearer's age, height, weight, gender or other such personalcharacteristics. These demographic factors can improve accuracy andserve as an additional input into the system as will be more fullydescribed herein with specific reference to weight.

To the extent that a particular module is utilized by more than oneindividual without resetting or clearing the database for thatidentified unit, wearer identification or demographics may also beembedded in the unit or its associated database of parameters, settings,preferences or values. These may be manually created during set up ormay be detected. With continuous measurement of temperature data,including a personalization period at the beginning of each new user'suse, the sensor suite may automatically recognize the wearer'sbiometrics and therefore proactively provide physiologically basedidentification information. In addition, this product could communicatewith an implantable identification chip in the body before it sends asignal from its wearer, detecting and incorporating the body identifierand integrating it into the reading protocol/header.

The step of feature creation 900 takes as input the temperature data orany other sensor data, which may or may not comprise calibrated signalsand produces new combinations or manipulations of these signals, such as[skin-temperature]3 or √[skin-temperature] which are created for use inthe rest of the algorithm. Additional examples include STD, MEAN, MAX,MIN, VAR and first derivatives thereof. Also, features such as insults,another term for urinations, or dislodgements of the sensor can beincluded as features that are themselves created by utilizing simpleevent detectors. These detected features can then be utilized as part ofregressions 1200. For example, detecting the active presence of fresh,warm urine by identifying the particular data output pattern of sharprises followed by gradual falls in ambient-side temperature on thefemoral modules, then using the maximum value of the rise as an inputinto the regressions. The feature is predicated on the fact that when achild urinates, the urine is at core body temperature and so can providean opportunity for calibration of the device against a known parameter.

Referring to FIG. 23, a urination insult is graphically illustratedutilizing three sensors in a multi module embodiment, having two femoralmodules, identified as left and right and one axillary module. All datais presented from ambient temperature sensor 120 of each module. Leftfemoral sensor output 901 and right femoral sensor output 902 trackrelatively similar curves, with a slight variation in detectedtemperature, which may be caused by variations in the sensorcalibrations or slightly different ambient environments within thediaper of the wearer. With respect to FIG. 23, the sensors are notlocated in the absorbent material of the diaper, and the insult isconsidered indirect. Axillary sensor output 903 provides a profile whichis radically different and provides no information with respect to theinsult. Between times T0 and T1, the system is in a warm up phase withthe temperature profiles of outputs 901, 902 normalizing to atemperature peak. At time T1, identified by line 904, an insult occurshaving peak temperature 905. A characteristic trough 906 in femoraloutputs 901, 902 without corresponding changes in axillary output 903indicates a localized event in the femoral region. The particular shapeof trough 906 represents the initial warmth of the core body temperatureurine's presence in the diaper and the subsequent cooling of the diaperand liquid. Secondary peak 907 occurs as the now-cooled urine is againwarmed by its presence near the body of the wearer. This feature ofurination is repeatable and detectable and is an example of the types ofpattern, context and event detection referred to within thisspecification. FIG. 23A provides an illustration of a direct insult, inwhich the sensor is placed within the absorbent material of the diaper,utilizing a single femoral ambient temperature sensor. This graphprovides a more characteristic example of urination or insult detection.At time T1, identified by line 904′, an insult occurs having peaktemperature 905′. A characteristic trough 906′ is once again observed infemoral output 901′, representing the initial warmth of the core bodytemperature urine's presence in the diaper and the subsequent cooling ofthe diaper and liquid. Secondary peak 907′ again is shown as thenow-cooled urine is again warmed by its presence near the body of thewearer. Of particular note is the sharp rise or slope of the curveimmediately prior to peak temperature 905′. This more characteristicfeature of urination is repeatable and detectable and is an example ofthe types of pattern, context and event detection referred to withinthis specification. The module is equally adaptable for the detection offeces, which presents a similar impact as urine.

If multiple contexts are simultaneously observed, then several solutionsare possible. One embodiment is to consider each combination of contextsto be its own context. Another is to identify a hierarchical order ofcontexts for choosing which is dominant.

While FIG. 23 does provide some indication of warm up, a morecharacteristic output is shown in FIG. 23B, which illustrates a lessgradual warm up profile than FIG. 23. It is important to note that thewarm up phase described with respect to FIGS. 23 and 23B ischaracteristic of each wearing or use cycle. This warm up phase hasstandard characteristics and can be easily modeled as a standardcontext. Simple techniques exist and are well known in the art foradjusting for such standard warm-up curves. These include simpleexponential models where the incoming signals are adjusted by a factorbased on the time since the module was affixed as well as models wherethe time since the start of the trial is an input into the regressionequations.

Smoothing 1000 utilizes dynamic and/or windowed models of discreteepochs of consecutive data to smooth out noisy values. For example, aBlackman smoother with a window of 30 seconds may be used to smooth outminor second to second variations in both the raw signals and thederived features. In one embodiment, each data point is smoothedaccording to a Blackman weighting function over the past 30 seconds.This function weights the current point 1050 the most highly and thenweights each prior point 1051 to a lesser degree, according to theBlackman function as shown in FIG. 24, illustrating point 1051 as 10seconds prior in time to point 1050. The function for a given point iscalculated the sum of the weighted recorded values divided by the sum ofthe weights. In another embodiment, the mean value of each 30 secondwindow is utilized. In another embodiment, data that deviates by morethan a present parameter are ignored. In yet another embodiment,smoothing is done using a probabilistic model such as a dynamicprobabilistic network. A variety of exact and approximate algorithms fordoing this smoothing exists in the literature.

Regressions 1200 are the equations that compute the estimated coretemperature for a given context. These equations can be very complex.One rather simple embodiment is the following:

EstimatedCoreTemp=A*SkinSideTemp+B*(SkinSideTemp−AmbientSideTemp)2+C

Where A, B and C are variable coefficients. Another example equation is:

A*weight+B*back25ModDiff+C*SqBack25ModDiff+D*ModMidWaist−S+E

Where back25ModDiff is the backward average of the difference betweenthe ambient and the skin sensor for the module over the last 25 seconds,SqBack25ModDiff is the average squared difference between the skin andambient sensors on the module over the past 25 seconds, ModMidWaistS isthe module skin temperature, and E is a constant offset. Anotherembodiment is to utilize a recognized context or feature formodification of the equation, rather than requiring a separate equation.For example, if a feature WithinInsult is created that represents theoffset that is expected to have been caused by an insult rather than acore-body-temperature change, then adding in a factor D*WithinInsultincreases the accuracy of the derived temperature. One such embodimentis as follows:

EstimatedCoreTemp=A*SkinSideTemp+B*(SkinSideTemp−AmbientSideTemp)2+D*WithinInsult+E*warmUpEffect+C.

Context detection 1100 recognizes and incorporates events, conditions,and activities that affect the thermoregulatory properties of thewearer, which are detected and taken into account. For example, warm-upcurves due to initial placement or dislodgement, urination heat-up andcool-down events, physical activity, and rest can all be detected. Thesecontexts are detected by any of a variety of techniques, including butnot limited to template matching, wavelet matching, decision trees,dynamic belief nets, neural nets, support vector machines, or rule-baseddetectors. One such example of a detector is a very simple rule forwarmup that equates any minute within 15 minutes of a sharp up-swing inskin-side temperature, defined as more than a one degree change within30 seconds. Other contextual filtering may also be necessary, such as ababy moving around, the diaper being taken off, clothing being takenoff, lifting up the arm, dislodgements, and the like. Dislodgementrecognition may also be enhanced by the inclusion of a heat flux sensor.In the preferred embodiment, these detectors are probabilistic.

In the preferred embodiment, in weighting step 1300, two main contextsare utilized, active and not-active. In this case, the estimates of theprobability of being active created by a probabilistic activitydetector, such as a naïve Bayes algorithm or a dynamic belief networkare first created. These are identified as P(context|Data). Thepredictions from each equation are then weighted by the probability ofthe associated context. If eq_active and eq_rest are two equations forpredicting core-body temperature, then:

P(active|Data)*eq_active+P(rest|Data)*eq_rest

is the equation for the estimate of core-body temperature.

Another embodiment utilizes features that correspond to adjusted valuesof the original temperature signals. For example, if a dip or a rise isexplained by other factors, such as an insult or an environmentaldisturbance, it can be smoothed out to produce a more accurate signal touse in the equations.

Another embodiment is to utilize dynamic belief nets for the entiresystem. Referring to FIG. 24A, a simple structure is illustrated of adynamic probabilistic network. T1 and T2 represent time-slices. C and c′are the core temperature at time T1 and time T2, respectively. K and k′are the context at time 1 and time 2. S and s′ are skin temperatures anda and a′ are the ambient temperatures. The arrows indicate causal links.The joint probability of the above system can be specified by thefollowing set of probability functions:

P(c), p(c′|c), p(k), p(k′|k), p(s|k,c), p(a|k,c).

Through the use of standard techniques from the graphical modelsliterature, an inference can be drawn computing the most likely coretemperatures over a period of time. Smoothing and context detection canbe directly performed by selecting an appropriate number of allowedcontexts and using standard techniques for training. An alternativeembodiment would utilize p(s′|k, c, s, a) instead of just p(s|k,c). Thisintroduces a time dependence to the raw sensors which can improvesmoothing.

The computational aspects of regressions 1200 are further refined as amethod of creating output data which is more accurate and representativeof the wearer's actual parameters than many prior art devices. In manycases, prior art devices and systems utilize a particular aspect ofmeasured data in order to reference a database of compiled average data.In many cases, this presents the appearance of individual data andreal-time accuracy, but in fact presents only a weighted average. For asimple example, a typical treadmill permits the input of the user'sweight and detects the time and speed of the user's activity. A databaseis provided with average values of calories expended for a user at eachweight gradation point per unit time. A simple relationship is madebetween the appropriate weight range, the time of activity and therelative amount of exertion, such as speed and distance. The presentembodiments described herein are directed toward the actual detection ofthe relevant physiological parameters necessary to derive the actualcondition of the user without reference to average or other pre-selecteddata libraries. In particular, mathematical functions and/or algorithmsare presented in which the value of one detected parameter effects howother detected parameters are mathematically treated. One example is asystem having two input variables X and Y, which represent the detecteddata streams from sensors and a function KNN which is an abbreviationfor K (a variable) Nearest Neighbors.

In this algorithm there is presented a set of data points for which theactual relevant values are known. In the example, a plane contains anumber of points. Each point has a value of O, therefore each pointx1,y1 has a value of O(x1,y1). Applying this to the current system, Xmay be the detected values of skin temperature, Y could be the detectedvalues of ambient temperature and O could be the true value of therectal temperature measured for that particular pair of measurements. K,a constant, is selected, usually a small value. In the degenerative caseit could be 1, which degenerates KNN to a lookup table, but typically Kwould be around 3 to 7. Next, a distance metric is selected for thesystem. The degenerative case is that all units are treated equally, butin the system where X is the skin temperature and Y is the ambienttemperature, the distance between two points in the X direction may bemore significant than in the Y direction. This may be accounted for by,for example, multiplying all X values by 2. Next, a contributionfunction is selected. For example, in attempting to predict the value Ofor a nearby point x2, y2, based upon O(x1,y1), a significantconsideration is the predicted distance from x2,y2 to x1,y1. Thedistance between x2,y2 and x1,y1 is established as D(x2,y2,x1,y1)) andmay be calculated or predicted as abs(x2−x1)+abs(y2−y1) where abs is theabsolute value. This is identified as the Manhattan distance but is notthe most typical way to calculate or predict the distance in associationwith the KNN function. More typically D(x2,y2,x1,y1) is defined assqrt((x2−x1)*(x2−x1)+(y2−y1)*(y2−y1)) where sqrt is the square root.

In this system, an algorithm must be developed to predict the correctvalue for some new point x′,y′. This will include the steps of: findingthe closest K points in your data space to x′,y′ which we'll call x1,y1through xk,yk. Next, the value of O(x′,y′) is set as the weightedaverage of O(xn,yn) for n=1 to K where the relative weight for xn,yn is1/D(x′,y′,xn,yn)2. This provides an example of how data KNN is using adata space of preselected data as the core of its algorithm. It shouldbe noted that KNN is using that data not simply to return some prioroutput value but to return some newly constructed output value which isparticularly appropriate given the sensed values of X and Y. The valuesof O for each data point may be retrieved from such a preselecteddatabase. In choosing not to do so and by actually making thecalculations as described herein, this technique presents theopportunity to find non-linear features of the data that exist betweenthe known points. If K=1, then the process devolves to merely retrievingthe data from a preselected data set or a lookup table. When K>1,however, then the opportunity is presented for the process to find newfacts in the data that don't exist in any of the data points bythemselves.

A simple symbolic example in which the value of one detected parameteraffects how other detected parameters are mathematically treated is: IfX is an even number, Result=X+Y, if X is an odd number, Result=X−Y. Inthis example Y has its contribution radically changed depending on thevalue of X. When X=18 and Y=9 the result is 27. But if X goes up by 1,the result is 10 because of how Y was used has changed so drastically.Another example is: if Y is even, divide by 2, else Y=3*Y+1, and repeatthe process X times using the previous output. When complete, return theend value of Y. This is a case where the value of X makes a substantialdifference in how Y affects the outcome because where you stop on thegrowing or shrinking of Y is decided very sensitively by the value of X.While more complex examples may be developed, the essence of theseexamples is that when utilizing conditional statements, the same resultscannot be derived from a fixed formula, database of preselected values,or a lookup table. Another important aspect of the system is that theresult of such a conditional test is not itself the answer or finaloutput of the derivation but is instead an equation to be evaluated or aprocedure to be executed which in turn produces the answer or output.Other examples include artificial neural networks, decision trees,dynamic belief nets, support vector machines, and hierarchical learnedalgorithms which create this same qualitative improvement in potentialfunctionality over lookup tables.

Although one can view an algorithm as taking raw sensor values orsignals as input, performing computation, and then producing a desiredoutput, it is useful in one preferred embodiment to view the algorithmas a series of derivations that are applied to the raw sensor values.Each derivation produces a signal referred to as a derived channel. Theraw sensor values or signals are also referred to as channels,specifically raw channels rather than derived channels. Thesederivations, also referred to as functions, can be simple or complex butare applied according to an algorithm on the raw values and, possibly,on already existing derived channels. The first derivation must, ofcourse, only take as input raw sensor signals and other availablebaseline information such as manually entered data and demographicinformation about the subject, but subsequent derivations can take asinput previously derived channels. Note that one can easily determine,from the order of application of derivations, the particular channelsutilized to derive a given derived channel.

One aspect of the present invention relates to a sophisticated algorithmdevelopment process for creating these algorithms for generatinginformation relating to a variety of variables from the data receivedfrom the plurality of physiological and/or contextual sensors. Suchvariables may include, without limitation, body temperature, energyexpenditure, including resting, active and total values, daily caloricintake, sleep states, including in bed, sleep onset, sleepinterruptions, wake, and out of bed, and activity states, includingexercising, sitting, traveling in a motor vehicle, and lying down, andthe algorithms for generating values for such variables may be based ondata from various additional sensors such as an accelerometer, heat fluxsensor, galvanic skin response sensor and the heart rate sensor,including an array of any of the above, in the embodiment describedabove.

Note that there are several types of algorithms that can be computed.For example, and without limitation, these include algorithms forpredicting user characteristics, continual measurements, durativecontexts, instantaneous events, and cumulative conditions. Usercharacteristics include permanent and semi-permanent parameters of thewearer, including aspects such as weight, height, and wearer identity.An example of a continual measurement is the skin, body and near ambienttemperatures and related contexts identified herein. Durative contextsare behaviors that last some period of time, such as sleeping, driving acar, or jogging. Instantaneous events are those that occur at a fixed orover a very short time period, such as an infant urinating in a diaper.Cumulative conditions are those where the person's condition can bededuced from their behavior over some previous period of time. Forexample, if a person hasn't slept in 36 hours and hasn't eaten in 10hours, it is likely that they are fatigued. Table 1 below shows numerousexamples of specific personal characteristics, continual measurements,durative measurements, instantaneous events, and cumulative conditions.

TABLE 1 personal age, sex, weight, gender, athletic ability,characteristics conditioning, disease, height, susceptibility todisease, activity level, individual detection, handedness, metabolicrate, body composition, similarity to prototypical individuals, geneticfactors continual mood, beat-to-beat variability of heart beats,measurements respiration, energy expenditure, blood glucose levels,level of ketosis, heart rate, stress levels, fatigue levels, alertnesslevels, blood pressure, readiness, strength, endurance, amenability tointeraction, steps per time period, stillness level, body position andorientation, cleanliness, mood or affect, approachability, caloricintake, TEF, XEF, ‘in the zone’-ness, active energy expenditure,carbohydrate intake, fat intake, protein intake, hydration levels,truthfulness, sleep quality, sleep state, consciousness level, effectsof medication, dosage prediction, water intake, alcohol intake,dizziness, pain, comfort, remaining processing power for new stimuli,proper use of the armband, interest in a topic, relative exertion,location, blood- alcohol level, sexual arousal, white blood cell count,red blood cell count, interest level, attention, nutrient levels,medication levels, pain levels durative exercise, sleep, lying down,sitting, standing, measurements ambulation, running, walking, biking,stationary biking, road biking, lifting weights, aerobic exercise,anaerobic exercise, strength-building exercise, mind-centering activity,periods of intense emotion, relaxing, watching TV, sedentary, REMdetector, eating, in-the-zone, interruptible, general activitydetection, sleep stage, heat stress, heat stroke, amenable toteaching/learning, bipolar decompensation, abnormal events (in heartsignal, in activity level, measured by the user, etc), startle level,highway driving or riding in a car, airplane travel, helicopter travel,boredom events, sport detection (football, baseball, soccer, etc),studying, reading, intoxication, effect of a drug, sexual rhythms andactivity, motorcycle riding, mountain biking, motorcross, skiing,snowboarding, user- defined activities, ongoing-pain instantaneousevents falling, heart attack, seizure, sleep arousal events, PVCs, bloodsugar abnormality, acute stress or disorientation, emergency, heartarrhythmia, shock, vomiting, rapid blood loss, taking medication,swallowing, sexual orgasm, acute pain, bowel movement, urination, onsetof sweating, transitions between activities, lying, telling the truth,laughter cumulative Alzheimer's, weakness or increased likelihood ofconditions falling, drowsiness, fatigue, existence of ketosis,ovulation, pregnancy, disease, illness, fever, edema, anemia, having theflu, hypertension, mental disorders, acute dehydration, hypothermia,being-in-the-zone, increased physical prowess, recovery from injury,recovery from disease, recovery from rehabilitation, risks of disease,life expectancy

It will be appreciated that the present system may be utilized in amethod for doing automatic journaling of a wearer's physiological andcontextual states. The system can automatically produce a journal ofwhat activities the user was engaged in, what events occurred, how theuser's physiological state changed over time, and when the userexperienced or was likely to experience certain conditions. For example,the system can produce a record of when the user exercised, drove a car,slept, was in danger of heat stress, or ate, in addition to recordingthe user's hydration level, energy expenditure level, sleep levels, andalertness levels throughout a day. These detected conditions can beutilized to time- or event-stamp the data record, to modify certainparameters of the analysis or presentation of the data, as well astrigger certain delayed or real time feedback events.

In some embodiments, the raw signals may first be summarized intochannels that are sufficient for later derivations and can beefficiently stored. These channels include derivations such assummation, summation of differences, and averages. Note that althoughsummarizing the high-rate data into compressed channels is useful bothfor compression and for storing useful features, it may be useful tostore some or all segments of high rate data as well, depending on theexact details of the application. In one embodiment, these summarychannels are then calibrated to take minor measurable differences inmanufacturing into account and to result in values in the appropriatescale and in the correct units. For example, if, during themanufacturing process, a particular temperature sensor was determined tohave a slight offset, this offset can be applied, resulting in a derivedchannel expressing temperature in degrees Celsius.

For purposes of this description, a derivation or function is linear ifit is expressed as a weighted combination of its inputs together withsome offset. For example, if G and H are two raw or derived channels,then all derivations of the form A*G+B*H+C, where A, B, and C areconstants, is a linear derivation. A derivation is non-linear withrespect to its inputs if it can not be expressed as a weighted sum ofthe inputs with a constant offset. An example of a nonlinear derivationis as follows: if G>7 then return H*9, else return H*3.5+912. A channelis linearly derived if all derivations involved in computing it arelinear, and a channel is nonlinearly derived if any of the derivationsused in creating it are nonlinear. A channel nonlinearly mediates aderivation if changes in the value of the channel change the computationperformed in the derivation, keeping all other inputs to the derivationconstant. Additionally a non-linear function may incorporate a number ofinputs, either weighted or un-weighted, may be added together and theirsum used as the independent variable against a non-linear function suchas a Gaussian curve. In this case both small and large values of the sumwill result in a value near zero and some narrow range of sums aroundthe “hump” of the Gaussian will return significantly higher values,depending on the exact shape and scale of the Gaussian.

Referring now to FIG. 25, the algorithm will take as inputs the channelsderived from the sensor data collected by the sensor device from thevarious sensors 700, 705 and demographic information for the individual.The algorithm includes at least one context detector 1100 that producesa weight, shown as W1 through WN, expressing the probability that agiven portion of collected data, such as is collected over a minute, wascollected while the wearer was in each of several possible contexts.Such contexts may include whether the individual was at rest or active.In addition, for each context, a regression 1200 is provided where acontinuous prediction is computed taking raw or derived channels asinput. The individual regressions can be any of a variety of regressionequations or methods, including, for example, multivariate linear orpolynomial regression, memory based methods, support vector machineregression, neural networks, Gaussian processes, arbitrary proceduralfunctions and the like. Each regression is an estimate of the output ofthe parameter of interest in the algorithm. Finally, the outputs of eachregression algorithm 1200 for each context, shown as A1 through AN, andthe weights W1 through WN are combined in a post-processor 1615 whichperforms the weighting functions described with respect to box 1300 inFIG. 22 and outputs the parameter of interest being measured orpredicted by the algorithm, shown in box 1400. In general, thepost-processor 1615 can consist of any of many methods for combining theseparate contextual predictions, including committee methods, boosting,voting methods, consistency checking, or context based recombination, aspreviously described.

In addition, algorithms may be developed for other purposes, such asfiltering, signal clean-up and noise cancellation for signals measuredby a sensor device as described herein. As will be appreciated, theactual algorithm or function that is developed using this method will behighly dependent on the specifics of the sensor device used, such as thespecific sensors and placement thereof and the overall structure andgeometry of the sensor device. Thus, an algorithm developed with onesensor device will not work as well, if at all, on sensor devices thatare not substantially structurally identical to the sensor device usedto create the algorithm.

Another aspect of the present invention relates to the ability of thedeveloped algorithms to handle various kinds of uncertainty. Datauncertainty refers to sensor noise and possible sensor failures. Datauncertainty is when one cannot fully trust the data. Under suchconditions, for example, if a sensor, for example an accelerometer,fails, the system might conclude that the wearer is sleeping or restingor that no motion is taking place. Under such conditions it is very hardto conclude if the data is bad or if the model that is predicting andmaking the conclusion is wrong. When an application involves both modeland data uncertainties, it is very important to identify the relativemagnitudes of the uncertainties associated with data and the model. Anintelligent system would notice that the sensor seems to be producingerroneous data and would either switch to alternate algorithms or would,in some cases, be able to fill the gaps intelligently before making anypredictions. When neither of these recovery techniques are possible, aswas mentioned before, returning a clear statement that an accurate valuecannot be returned is often much preferable to returning informationfrom an algorithm that has been determined to be likely to be wrong.Determining when sensors have failed and when data channels are nolonger reliable is a non-trivial task because a failed sensor cansometimes result in readings that may seem consistent with some of theother sensors and the data can also fall within the normal operatingrange of the sensor. Moreover, instead of displaying either of a resultor an alarm condition, the system may provide output to the user orcaregiver which also identifies a possible error condition, but stillprovides some substantive output.

Clinical uncertainty refers to the fact that different sensors mightindicate seemingly contradictory conclusions. Clinical uncertainty iswhen one cannot be sure of the conclusion that is drawn from the data.For example, one of or the combined temperature sensor reading and/oraccelerometers might indicate that the wearer is motionless, leadingtoward a conclusion of a resting user, the galvanic skin response sensormight provide a very high response, leading toward a conclusion of anactive user, the heat flow sensor might indicate that the wearer isstill dispersing substantial heat, leading toward a conclusion of anactive user, and the heart rate sensor might indicate that the wearerhas an elevated heart rate, leading toward a conclusion of an activeuser. An inferior system might simply try to vote among the sensors oruse similarly unfounded methods to integrate the various readings. Thepresent invention weights the important joint probabilities anddetermines the appropriate most likely conclusion, which might be, forthis example, that the wearer is currently performing or has recentlyperformed a low motion activity such as stationary biking.

According to a further aspect of the present invention, a sensor devicemay be used to automatically measure, record, store and/or report aparameter Y relating to the state of a person, preferably a state of theperson that cannot be directly measured by the sensors. State parameterY may be, for example and without limitation, body temperature, caloriesconsumed, energy expenditure, sleep states, hydration levels, ketosislevels, shock, insulin levels, physical exhaustion and heat exhaustion,among others. The sensor device is able to observe a vector of rawsignals consisting of the outputs of certain of the one or more sensors,which may include all of such sensors or a subset of such sensors. Asdescribed above, certain signals, referred to as channels, may bederived from the vector of raw sensor signals as well. A vector X ofcertain of these raw and/or derived channels, referred to herein as theraw and derived channels X, will change in some systematic way dependingon or sensitive to the state, event and/or level of either the stateparameter Y that is of interest or some indicator of Y, referred to asU, wherein there is a relationship between Y and U such that Y can beobtained from U. According to the present invention, a first algorithmor function f1 is created using the sensor device that takes as inputsthe raw and derived channels X and gives an output that predicts and isconditionally dependent, expressed with the symbol _(π), on (i) eitherthe state parameter Y or the indicator U, and (ii) some other stateparameter(s) Z of the individual. This algorithm or function f1 may beexpressed as follows:

f1(X)_(π)U+Z

or

f1(X)_(π)Y+Z

According to the preferred embodiment, f1 is developed using thealgorithm development process described elsewhere herein which usesdata, specifically the raw and derived channels X, derived from thesignals collected by the sensor device, the verifiable standard datarelating to U or Y and Z contemporaneously measured using a method takento be the correct answer, for example highly accurate medical grade labequipment, and various machine learning techniques to generate thealgorithms from the collected data. The algorithm or function f1 iscreated under conditions where the indicator U or state parameter Y,whichever the case may be, is present. As will be appreciated, theactual algorithm or function that is developed using this method will behighly dependent on the specifics of the sensor device used, such as thespecific sensors and placement thereof and the overall structure andgeometry of the sensor device. Thus, an algorithm developed with onesensor device will not work as well, if at all, on sensor devices thatare not substantially structurally identical to the sensor device usedto create the algorithm or at least can be translated from device todevice or sensor to sensor with known conversion parameters.

Next, a second algorithm or function f2 is created using the sensordevice that takes as inputs the raw and derived channels X and gives anoutput that predicts and is conditionally dependent on everything outputby f1 except either Y or U, whichever the case may be, and isconditionally independent, indicated by the symbol

, of either Y or U, whichever the case may be. The idea is that certainof the raw and derived channels X from the one or more sensors make itpossible to explain away or filter out changes in the raw and derivedchannels X coming from non-Y or non-U related events. This algorithm orfunction f2 may be expressed as follows:

f2(X)

Z and (f2(X)

Y or f2(X)

U

Preferably, f2, like f1, is developed using the algorithm developmentprocess referenced above. f2, however, is developed and validated underconditions where U or Y, whichever the case may, is not present. Thus,the verifiably accurate data used to create f2 is data relating to Zonly measured using highly accurate medical grade lab equipment.

Thus, according to this aspect of the invention, two functions will havebeen created, one of which, f1, is sensitive to U or Y, the other ofwhich, f2, is insensitive to U or Y. As will be appreciated, there is arelationship between f1 and f2 that will yield either U or Y, whicheverthe case may be. In other words, there is a function f3 such that f3(f1, f2)=U or f3 (f1, f2)=Y. For example, U or Y may be obtained bysubtracting the data produced by the two functions (U=f1−f2 or Y=f1−f2).In the case where U, rather than Y, is determined from the relationshipbetween f1 and f2, the next step involves obtaining Y from U based onthe relationship between Y and U. For example, Y may be some fixedpercentage of U such that Y can be obtained by dividing U by somefactor.

One skilled in the art will appreciate that in the present invention,more than two such functions, e.g. (f1, f2, B3, . . . f_n−1) could becombined by a last function f_n in the manner described above. Ingeneral, this aspect of the invention requires that a set of functionsis combined whose outputs vary from one another in a way that isindicative of the parameter of interest. It will also be appreciatedthat conditional dependence or independence as used here will be definedto be approximate rather than precise.

The method just described may, for example, be used to automaticallymeasure and/or report the body temperature of an infant, or the factthat a child is about to wet their bed or diapers while asleep at night,or caloric consumption or intake of a person using the sensor device,such as that person's daily caloric intake or any other data from Table1.

Another specific instantiation where the present invention can beutilized relates to detecting when a person is fatigued. Such detectioncan either be performed in at least two ways. A first way involvesaccurately measuring parameters such as their caloric intake, hydrationlevels, sleep, stress, and energy expenditure levels using a sensordevice and using the two function (f1 and f2) approach to provide anestimate of fatigue. A second way involves directly attempting to modelfatigue using the direct derivational approach described in connectionwith FIG. 25. This example illustrates that complex algorithms thatpredict the wearer's physiologic state can themselves be used as inputsto other more complex algorithms. One potential application for such anembodiment of the present invention would be for first-responders (e.g.firefighters, police, soldiers) where the wearer is subject to extremeconditions and performance matters significantly. In a pilot study, theassignee of the present invention analyzed data from firefightersundergoing training exercises and determined that reasonable measures ofheat stress were possible using combinations of calibrated sensorvalues. For example, if heat flux is too low for too long a period oftime but skin temperature continues to rise, the wearer is likely tohave a problem. It will be appreciated that algorithms can use bothcalibrated sensor values and complex derived algorithms. Referring nowto FIG. 26, a graphical illustration represents a firefighter skintemperature during a training exercise in which a fire retardant suithaving limited ventilation is worn. The area between times T0 and T1indicates the baseline or normal readings for the device having a heatflux sensor, the output of which is identified as heat flux output 935,and a skin temperature sensor, the output of which is identified as skintemperature output 926. At time T1, indicated by line 921, the suit isdonned. The effort expended in donning the suit is reflected by peak925A of heat flux output 925, with a subsequent immediate drop in output925 as the effects of the absence of ventilation within the suit isshown. Skin temperature output 926 shows little change until thebeginning of the exercise at time T2, identified by line 922. While theheat flux output 925 continues to drop, skin temperature output 926shows a consistent and linear rise in temperature through the end of theexercise at time T3 shown ant line 923. The suit is removed at time T4,line 924. A sharp spike 927 in heat flux output is illustrated as thesuit is removed. The outputs 925, 925 provide consistent data for whichpredictions may be made by extrapolated data points. Most importantly,given a known target for a parameter, for example skin temperature, awarning could be sounded prior to a catastrophic event, such as heatexhaustion or suffocation. The use of secondary data types, such as theheat flux output, serves to provide confirmation that differentialevents are or are not occurring. Referring back to FIG. 23, the readingfrom the axillary sensor indicates the localized nature of thetemperature changes as seen in the femoral region and rules outdifferential events, such as the patient being immersed in water.

Additional functionality relating to this capability relates to theadaptation of the system to the detected condition. New patterns anddata, once categorized, serve to improve predictability of similar orrelated events in the future. Upon remedying the situation, thepredictive clock could be easily reset or newly adjusted, taking intoaccount the identified event, but also evaluating the data for the timeperiod prior to the event, creating new threshold identifiers for theevent type.

Referring now to FIG. 27, the output of several sensors is illustrated,together with the data from output 1400 also presented for two modules.The data for FIG. 27, similar to that of FIG. 23, is drawn from left andright femoral sensors and an axillary sensor. Each sensor has a skintemperature output and an ambient temperature output, consistent withthe description of FIG. 23. The axillary module is therefore supplyingaxillary ambient temperature output 903 and axillary skin temperatureoutput 951. The left femoral module is supplying left femoral ambienttemperature output 901 and left femoral skin temperature output 953. Theright femoral module is supplying right femoral ambient temperatureoutput 902 and right femoral skin temperature output 952. A rectalsensor is placed to provide a baseline core temperature reading to whicheach other measurement is correlated and is illustrated by rectal sensoroutput 954. The derived temperature output of each femoral module isillustrated as left femoral derived temperature output 956 and rightfemoral derived temperature output 955.

While certain rough correlations may be drawn from FIG. 27, it isapparent upon even a casual review that the various detected skin andambient temperature bear little direct correlation to the measuredrectal temperature. Axillary ambient temperature is particularlyaffected by body movement and activity, which forms the basis for theuse of this output in many activity related contextual determinations,as will be described more fully herein. As with FIG. 23, a pronouncedwarm up period is indicated at the leftmost side of the graph.Additionally, peak 905 illustrates the insult more fully described withrespect to FIG. 23. Left femoral derived temperature output 956 andright femoral derived temperature output 955, however, show closecorrelations to the measure rectal output 954, especially after the warmup period and recovery from the insult have occurred, as illustrated atthe right most section of FIG. 27.

As previously described, the additional parameters may be added toincrease the accuracy of derived temperatures. It is also possible thatcore body temperature may be predictable with no temperaturemeasurements if an appropriate selection of other sensors are utilized,such as heart rate, galvanic skin response and motion. Additionalparameters may be used to eliminate obviously compromised data as wellas to assist in the selection of appropriate algorithms for contextualapplication. In many cases, however, additional parameters areincorporated into the derivation of the temperatures themselves asadditional factors or coefficients. More specifically, referring now toFIG. 28, the effect of adding the additional parameter of body weight tothe previously described derivations is illustrated. Rectal temperaturedata output 954 again provides a baseline for correlation of the derivedmeasurements. Derived temperature output 957 may be taken from a singlemodule or a combination of multiple modules. In either case, derivedtemperature output 957 is fairly consistent in tracking the actualrectal temperature within a mean error of better than 0.2 degreesCelsius and more preferably better than the 0.177 degrees Celsius shownin FIG. 28. Clinical or medical applications require an accuracy levelhaving a mean error of better than 0.5 degrees Celsius. With theaddition of the weight parameter in the derivation of the temperature,weight adjusted derived temperature output 958 is reflective of theactual rectal temperature output 954 within 0.155 degrees Celsius. Theseresults generally result in a 10% improvement in derived temperature issolely attributable to the addition of this one parameter. FIG. 28reflects a 16% improvement in accuracy.

FIG. 29 illustrates the use of an ambient temperature sensor as anactivity detector. The graph shows output of the variance of an ambienttemperature sensor one second intervals over five minute periods forPatient A on the left and Patient B on the right. Patient A wassedentary for the majority of the test period. Patient B was active. Thegraph of Patient B's periodic temperature readings over time indicatethe heightened temperature sensed in the near body areas. This is alsotrue of ambient temperature sensors which are not contained within adiaper or clothing. The number of peaks as well as their quantitativevalue provides good insight into the activity level of the patient.While not as quantitatively accurate as an accelerometer, qualitativelythe ambient temperature sensor provides a significant amount of datarelating to the relative movement of the wearer's body, which can beuseful for a number of derivations as will be described more fullyherein. It should be specifically noted that one embodiment of thedevice may monitor only ambient temperature in order to provide basicactivity data of the wearer.

FIGS. 30 and 31 also illustrate additional types of informationregarding context and activity level which can be derived from the useof the temperature module and the associated processing. The figuresboth illustrate the output of two modules, one being placed in thefemoral region and one at the waist area. In this particular instance,the locations are not relevant to the determination. Femoral skintemperature output 981, femoral ambient temperature output 979, waistskin temperature output 982 and waist ambient temperature output 978 aregraphed against time. Each shows a relative period of interest from timeT1 to time T2. In FIG. 30, times T1 and T2, demarcated by lines 976,977, respectively, indicate a period of sleep for an infant patientwhile being held by its mother. FIG. 31 indicates a similar time perioddemarcated by lines 976A, 977A, during which the infant was asleep in acar seat. It is important to note both the consistency of data from allfour sensors during the period of sleep, as well as the distinctdifferences between the graph characteristics. The sleeping child inFIG. 31 has a slowly dropping temperature, consistent with general,unencumbered sleep. The child held while sleeping in FIG. 30, however,maintains a relatively flat temperature profile during this time period.It is therefore possible to determine whether an infant is being held,and for what time periods. Additionally, periods of sleep may bedetected and recorded.

The device is also able to detect appropriate data to derive theproximity of other humans to the patient as mentioned above. However,other methods may be employed to detect the presence of bodies near thesensor. Proximity detection currently involves either: (i) detecting thepresence of a preselected device with a matched detector or (ii) usingexternal equipment such as a video camera or motion sensor. There iscurrently no way to conveniently know when a person gets close to anobject. What is disclosed herein is intended to detect the motion of anobject that can hold a significant static charge within a few feet ofthe sensor. It is further known that, because this detection is basedupon a magnetic field, the relationship between the signal strength ordetected charge and distance is correlated to strength=1/distance2. Thehuman body, as it is made mostly of water, has this property in a waythat most solid inanimate objects, such as a chair, do not. In principlea cat or dog moving by such a sensor could be mistaken for a person butbecause those animals hold much less charge than even a child, theywould have to be much closer to register the same effect on the sensor.

A proximity detector of this type utilizes an R/C oscillator constructedaround the ambient capacitance of a copper plate. As the environmentsurrounding the plate changes, such as mounting the device on the humanbody or moving other objects closer/farther from the device armband, thecapacitance of the plate changed leading to a change in the frequency ofthe oscillator. The output of the oscillator is then input into acounter/timer of a processor. Another embodiment utilizes a shortantenna tied to the input of a FET transistor with very high gate inputimpedance. Very slight changes in the environment surrounding theantenna caused very detectable changes in the output of the FETamplifier. When the circuit is moved through the air toward otherobjects and when objects are moved closer to the antenna, changes inoutput were detected. The charge reflecting the motion is believed to bestatic in nature.

In addition to capacitance and other techniques described above, othersensors may be utilized to provide or enhance this type of proximitydetection, including galvanic skin response, heat flux, sound and motionto help recognize these context points with greater confidence, accuracyand reliability.

A proximity detector, as described above, may have many applications.These include the use of the device to interact with a computer so thatthe screen saver, instead of being time-based after the last time youhit a key, turns on as soon as you walk away and comes back to thenormal screen as soon as you sit down, without needing to initiatecontact. The backlighting for remote controls, light switches, phones,or other items used in the dark may be activated when a body is present,together with the lights or devices controlled thereby. A child-proofgate may be designed such that it is unlocked or even swung open when anadult is present but not when a child is alone nearby. A cell phone orother communication device might be aware if the user is carrying it onhis or her person or has it nearby, such as on a night stand. The devicemight be programmed with two different modes in the two situations tosave power, download emails or the like, as appropriate.

Safety-related implementations may include the ability to know if aperson has approached or opened a liquor, gun or money cabinet[[.]], orthe detection of people near a hazardous site or situation, including apool or beach, when no supervision is present. A device embedded in akey fob or other device might provide the ability to detect whether aperson is approaching in a dark parking lot or around a corner of abuilding. With respect to automobiles, the device may detect whether anadult or child is in the driver's seat and disable the ignition.

A number of entertainment related embodiments are also contemplated. Avideo game may be provided when a player is running towards the screento zoom in but as the player runs away from the screen it zooms back tonormal view or even further out. Similarly, in a non-video game, if twoplayers are playing with a ball, and as the ball comes closer to them,it glows more brightly, but as it is thrown away from them it growsdimmer until it reaches another person. This system may also detect theapproach of an adult, which triggers the ball to discontinue the effect.Expanding the concept to the colorful ball pits in shared playlands,where as the child crawls and jumps through them, the mass of ballsdirectly by them are glowing, while the ones to the other side of thepit are glowing for another child or dark because there is no childthere. Lastly, a video wall may be provided which displays a shadow of astylized image of the user. If the user moves his or her hand closer tothe wall, that area about the size of the hand becomes darker in thatvicinity but may also become a virtual pointer or paint dispenser can todraw on this wall. This easily extends to making water fountainsresponsive to children playing in them by manipulating and controllingthe water jets to chase a child or create a pattern around the child'sproximity. Conversely, the system could stop the specific jet that thechild is standing above, making the child the chaser of the water jets.Again, this could be a special child-only effect which discontinues nearadults.

FIG. 32 illustrates another distinct illustration for detection of aparticular event or activity. A single femoral module is utilized,producing femoral skin temperature output 979 and femoral ambienttemperature output 981. In this illustration, the patient's diaper wasremoved for collecting the rectal data point 991 at time point T1. Acharacteristic trough 992 immediately preceding time point T1 in femoralambient temperature output 981 without corresponding changes in femoralskin temperature sensor output 979 indicates the sudden change inambient conditions without change in skin temperature. This pattern isidentifiable and repeatable and may be detected reliably once the systemlearns to observe the relevant parameters.

Similarly, FIG. 33 illustrates the determination between resting andactivity. Consistent with the findings associated with FIGS. 27 and 29,activity can be monitored through the use of the ambient temperaturesensors. In this instance, consistent with FIG. 27, three modules wereapplied to the patient, being left and right femoral and axillary.Outputs include left femoral ambient temperature output 901, rightfemoral ambient temperature output 902 and axillary ambient temperatureoutput 903. During the time period from time T0 to time T1, indicated atline 993, the patent was active, as is characterized by the generallyrandom and periodic changes in ambient temperature, as well as the smallintermediate peaks of the larger features. These are exemplified by peak1001 which further comprises a series of intermediate peaks 1001′. Attime T1, the patient became sedentary while reading. Instantaneouschanges in both the qualitative value and waveform characteristics arenoted in the time period immediately subsequent to time T1 in theaxillary ambient temperature output 903. While some changes are evidentin the femoral outputs during this same time period, when viewed in thelight of the entire graph for the femoral outputs, the changes areindistinct and unremarkable. What is notable, however, is the ability todetect periods of activity and rest, together with the interface of thetwo at a particular and identifiable moment in time. The activitymonitor may also detect the wearer falling and sound an alarm or warningto a parent or caregiver.

While the activity monitoring functions of the device, as described morefully herein, are useful for a number of applications, they are notentirely accurate. The device can, however, accurately determine andrecognize sleep and sedentary situations because the sensors are steadyand are tracking close together. A monitor might therefore be providedthat reports how much the user was active during a given period bysubtracting inactivity from total time. An accelerometer may be added tomore accurately measure physical activity. The temperature sensor,however, improves the ability to filter out contexts like motoring,which create inaccuracies in accelerometer-based detectors, includingpedometers and energy expenditure monitors.

Some important applications for the various detection capabilitiesdescribed above are: (i) monitoring of infants and children in day careor other extended non-parental supervision and (ii) the increasinglyimportant monitoring of elderly patients under institutional or othernursing care. In both cases, significant opportunities arise for bothabuse and neglect of the people under care. Additionally, the familiesand/or parents of these individuals have a constant concern regardingtheir ability to both monitor and evaluate the care being provided,especially when they are not physically present to observe or enforceappropriate care. The system described herein may be well utilized toplace a reliable and tamper resistant watch on the patient, while theobserver may track progress and care from a remote location with assimple a device as a baby-monitor style receiver, or any computingdevice connected to an appropriate network for receiving the output ofthe device according to the broader teachings of Teller, et al.,copending U.S. patent application Ser. Nos. 09/595,660 and 09/923,181.Extrapolations of the data and derived information presented hereininclude the ability to determine the nature and frequency of urinationand bowel movement events, corresponding diaper changes, teething pain,periods of close interaction with other humans, times being held, sleeptime, cumulative lack of sleep, activity time, repositioning forbedridden patients, shaking or other physical abuse, overheating and thelike. The device may also be provided with the ability to recognizefeeding patterns and predict/alert a caregiver that it is time for thenext feeding. This can be accomplished through the use of the activitymonitoring abilities of the device to make a rough calculation of energyexpended or merely recognizing a timing pattern.

The device may further be provided with a unique identification tag,which may also be detectable through wireless or other proximity relatedtransmission such that each module can detect and record which othermodules have come within a certain perimeter. This may have applicationsin military, institutional and educational settings, where it is usefulto know, not only where people are, but with whom they have come intocontact. This may also be useful in a bio- or chemical terrorism attack.Moreover, in the child care setting described above, it may be usefulfor a parent or caregiver to assess the level and type of social contactof each child.

With respect to infants and other non-communicative children and adults,the device may be utilized to determine environmental temperaturecomfort level. This may be related to determining whether the wearer istoo hot or too cold in a particular room or whether the clothing beingworn is too heavy or too light. Similar to the bathroom training exampleabove, a learning period may be necessary to determine the particularcomfort zone of each wearer as well as any ancillary physiological oremotional responses detected during and prior as well as subsequent tothe individual getting to such a state. Additionally, certaingeneralized comfort temperature zones may be provided with the devicefor use prior to or in lieu of personalization. At its most extreme, thedevice may also detect hypo- and hyperthermia, shivering or a rise inbody or skin temperature to levels of concern as referenced with respectto the firefighter example, above.

In many situations, including new parents, new caregivers or changes incare responsibilities, infants may be placed in situations withinexperienced supervision. Crying, in infants, is a primary means ofcommunication. Unfortunately, there are many reasons why infants arecrying and inexperienced caregivers are frequently at a loss to diagnosethe problems. The device may be adapted to determine, through detection,derivation of data and/or process of elimination, why an infant iscrying. While this is particularly useful for infants, it is alsoclearly applicable to non-communicative adults and the elderly.

The system may determine that the wearer has a fever through the use oftemperature sensing. It may determine that the diaper is soiled in thesame manner. Temperature sensing, as described above, may also provideinformation as to whether the wearer is too hot or too cold. A number ofdeterminations may also be made based on patterns of behavior. Infantsespecially eat on a regular schedule and the timing of feedings may bedetected and/or derived and reported. Additionally, these events may bepredicted based on the patterns detected, as presented with respect toovulation, bed wetting and the like. Hunger may also be detected throughthe use of microphones or other audio detectors for bowel and stomachsounds. Finally, lack of sleep is another pattern-based behavior thatmay be predicted or detected, especially when additional parametersrelated to or affected by lack of sleep are detected, recognized orderived, such as changes in immune response, alertness and socialskills.

The system may be provided with the ability to create reports of eachwearer's daily routine. While this may be most useful to a parent orcaregiver to assess what has happened to the wearer over a past periodof time, it may also be used as a predictor of scheduled or patternbehavior. This may be most useful for a new caregiver or baby sitter,for example, to be presented with a map of the supervised time periodwhich includes most expected events or behaviors.

In tracking consistent or pattern activities over time, changes inpatterns or physiological parameters may be detected. This is especiallytrue of small changes which occur over long periods of time. This mayaid in the detection or diagnosis of certain diseases or conditions. Itmay also be useful in creating correlations between detectedphysiological parameters, contexts, derived parameters and combinationsof the above. For example, it may be come apparent after some period oftime that high quality sleep is correlated to significant exercisewithin a preceding 6 hour period of time. Additionally, it may becomeapparent that more significant weight loss is highly correlated tobetter sleep patterns.

As infants grow and mature, changes occur in the patterns and values oftemperature changes within the body. Infants with poorly developedtemperature regulatory systems exhibit sharp swings and spikes in theirtemperature profile. As the body matures, as well as grows and adds fat,these temperature swings become less severe. The system may then providean assessment of development based upon continued recording of thesetemperature fluctuations over time.

In many situations, such as administration of medication, physicaltherapy or activity limitations in pregnant women, compliance with aproper routine over time is essential. In many cases, even theindividual is unable to assess the qualitative nature of their owncompliance with a prescribed routine or program. In other cases, amedical professional or caregiver must assess and monitor the level ofcompliance of a patient. The system provides the ability to make theseassessments without significant interference and with confidence in theresults. In this situation, an insurance company or employer may use thesystem to collect and/or produce reports to the extent to which a weareris following a program or reaching certain goals. These reports may thenbe transmitted for analysis to the insurance company or employer.

Many of the features and functionality described herein are based on thedetection of certain parameters; the derivation of certain contexts,parameters or outcomes and the appropriate identification of certainevents and contexts. The ability of the system to accurately make thesedeterminations is proportional to the sample size and knowledge base.This is applicable both in terms of the detection of a particular eventby the nature and interaction of the detected signals, such as aurination insult, but also in the development of more accuratealgorithms which make the determinations. The system is specificallyadapted to communicate with a larger system, more specifically a systemaccording to Teller, copending U.S. patent application Ser. No.09/595,660. This system may include the collection of aggregate datafrom a number of wearers, together with the correlated data andderivations, in order to more accurately recognize the signals whichprecede identified events. Modifications in the system processing and/oralgorithms may then be retransmitted to the user's systems and modulesas an update.

Two other important aspects of any monitoring device must be addressed:detecting the failure of the unit and preventing external factors fromupsetting the system. With respect to dislodgement of the module fromits appropriate mounting position, FIG. 34 illustrates the easilydetectable patterns and data associated with this event. As with FIG.33, three modules were applied to the patient, being left and rightfemoral and axillary. Outputs include left femoral ambient temperatureoutput 901, right femoral ambient temperature output 902 and axillaryambient temperature output 903. At time point T1, identified by line1010, the axillary sensor became dislodged at peak 1002. Trough 1002′ isinstantly created in the data record. At time point T2, identified byline 1015, the right femoral sensor became dislodged at peak 1003 andtrough 1003′ is created in the data. It should be noted that the shapeof waveform 1003′ is more typical of dislodgement wave patterns. Thesesudden changes in temperature, coupled with no corresponding change inother sensors, such as left femoral ambient temperature output 901during either event, reliably and consistently identifies this failureand provides the ability to notify a caregiver to remedy the situation.

An additional functionality of the device is the ability to utilizesensed parameters, derived parameters and contexts to control otherdevices. For example, if the system senses that the user is too cold, itcan generate a signal to a thermostat to raise the temperature of theroom in which the user is located. Moreover, the system can detect sleepstates and prevent phones from ringing or turn the lights or televisionoff during such periods. The device may, through the temperature sensingand motion detection functionalities described above, also be utilizedas a pointing device for interaction with a computer or video gamesystem. The system may also be utilized, similar to the video game, fordetection of emotional or physiological states utilizing signals ormethods known in the field of biofeedback, or for detection of gesturesby the wearer and use biofeedback or those detected gestures to controlanother device. Gestures can include particularized motions of limb,limbs and/or full body. Devices controlled include stage lighting,projectors, music and dance club floors with interactive lighting. Musicdevices may include stage-based devices as well as group or personal MP3players.

Although particular embodiments of the present invention have beenillustrated in the accompanying drawings and described in the foregoingdetailed description, it is to be further understood that the presentinvention is not to be limited to just the embodiments disclosed, butthat they are capable of numerous rearrangements, modifications andsubstitutions, as identified in the following claims.

1. An apparatus for monitoring human status parameters, comprising: atleast one ambient temperature sensor for detecting and generating dataindicative of another temperature condition; and a processor inelectronic communication with said at least one sensor, said processor:(i) receiving at a least a portion of said data indicative of saidtemperature and (ii) deriving a parameter comprising at least one of:body states of, activities of and events relating to said wearer.